JP6999005B2 - 人工心臓弁 - Google Patents
人工心臓弁 Download PDFInfo
- Publication number
- JP6999005B2 JP6999005B2 JP2020154483A JP2020154483A JP6999005B2 JP 6999005 B2 JP6999005 B2 JP 6999005B2 JP 2020154483 A JP2020154483 A JP 2020154483A JP 2020154483 A JP2020154483 A JP 2020154483A JP 6999005 B2 JP6999005 B2 JP 6999005B2
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- Prior art keywords
- valve
- stent
- collar
- tissue
- artificial
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 0 C(*1)C11C(C2)C2C*1 Chemical compound C(*1)C11C(C2)C2C*1 0.000 description 1
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Description
[連邦政府によって支援された研究または開発に関する声明]この発明を研究または開発するのに連邦政府資金は使われなかった。
[共同研究合意した個人または団体]適用外
[ここに引用によって組み込まれ含まれる配列一覧]適用外
この発明は、経カテーテル僧帽弁置換補綴とそのための配送デバイスを含むがそれらに限定はされない、人工弁についての様々な改良に関する。
好ましい実施形態では、膨張可能な管状ステントと膨張可能な内部弁尖アッセンブリーを有する人工心臓弁のための多層カバーであって、前記ステントは、内壁と外壁を有する管状ワイヤーフォームであり、前記弁尖アッセンブリーは、弁を形成するようにステント内に配置され、安定化された組織または合成材料からなり、多層カバーは、安定化された組織または合成材料の少なくとも2つの層からなり、第1の層はポリエステル材料からなり、第2の層はポリエステル材料または安定化された組織からなり、第1の層がステントの内壁に取り付けられ第2の層がステントの外壁に取り付けられている、多層カバーが提供される。
別の実施形態では、心室心筋への係留のためにテザーを使う自己拡張するニチノール本体によってサポートされた人工心膜弁が提供される。
一実施形態では、人工心膜弁ステントへの取り付けと腱索の周回のために形造られた形状記憶特性をもった少なくとも2つのコイルからなる、ばね形状のアンカー。
一実施形態では、(a)ピンで作られ、オプションでばねによって取り囲まれた蝶番であって、前記ピンは、2つの互いに組み合わされた中間部材中の穴を通して伸びており、該蝶番は、閉じたかまたは開いた位置に操作されることができるものと、(b)各中間部材が、(i)近位側と遠位側をもったフッターセクションと、(ii)2つの平坦なプレートで、各プレートの遠位端がフッターセクションの近位側の狭いエッジに取り付けられて、調節可能な角度で平行にそこから伸びるものと、(iii)各そのようなプレートの近位端が、ピンの挿入に適応するような直径の中心に位置する円形の穴を含むものと、(iv)フッターセクションの内部端の中心から平坦なフランジが突出し、そのようなフランジが、蝶番を開いたり閉じたりするように、耐圧部材が取り付けられることを許容するための中心に位置する穴を含むものと、からなるものと、(c)2つ以上の半円形のフィンガーであって、蝶番を閉じた際に、半円形の開いた側が内向きに面し、閉じた側が外向きに面するように、等しい数のそのようなフィンガーが各中間部材の遠位端に取り付けられており、フィンガーまたはフィンガーの二重のセットが、蝶番が閉じるにつれてお互いに向かって動き、蝶番が開くにつれてお互いから離れるように動くものと、(d)閉じた際に半円形のフィンガーが互いに組み合わされるようなずらされたやり方で中間部材に取り付けられているものと、(e)各半円形のフィンガーの先端が、弁輪組織を貫通することが可能な尖りを形成するように先細りになっているものと、からなる人工弁クランプ。
一実施形態では、経カテーテル配送システムを使って閉じた脈動する心臓中に配備されることができる、改良された輪郭をもった心房カフ/カラーを有する圧縮可能な人工心臓弁置換の改良されたデザインと機能。議論されるデザインは、最小侵襲性のやり方を介したデバイスの配備に焦点を当てており、例として、肋間または剣状突起下のスペースを弁導入のために利用する最小侵襲性の外科手術を考える。これを達成するために、弁は、それが配送システム内にフィットするように圧縮され、二次的に配送システムから標的位置、例えば僧帽弁または三尖弁の弁輪中に排出されることができるようなやり方で形成されている。
実施形態は、経カテーテル配送システムを使って閉じた脈動する心臓中に配備されることができる、改良されたステント構造-機能プロファイルを有する予め構成された圧縮可能な経カテーテル人工心臓弁置換のデザインと機能に関する。議論されるデザインは、最小侵襲性のやり方を介したデバイスの配備に焦点を当てており、例として、肋間または剣状突起下のスペースを弁導入のために利用する最小侵襲性の外科手術を考える。これを達成するために、弁は、それが配送システム内にフィットするように圧縮され、二次的に配送システムから標的位置、例えば僧帽弁または三尖弁の弁輪中に排出されることができるようなやり方で形成されている。
実施形態は、経カテーテル配送システムを使って閉じた脈動する心臓中に配備されることができる、狭い直径のステント本体を有する圧縮可能な人工心臓弁置換のデザインと機能に関する。議論されるデザインは、生来の僧帽弁弁輪内にフィットするが、生来の僧帽弁弁尖の終端に位置する生来の交連弁尖を圧縮またはその開閉と実質的に干渉はしない、人工僧帽弁に焦点を当てている。
一実施形態では、発明は、経カテーテル配送システムを使って閉じた脈動する心臓中に配備されることを意図された人工弁についての表面コンポーネンツと構造における改良を提供する。ここでの固有の特徴の組み合わせは、現行の弁技術における問題点および欠陥点の多くに対処し、このタイプの医療用デバイスを提供しようとした時に生じる並外れた数の問題への高度に発展したアプローチを提供する。発明は、改良された補綴の内殖を提供し、大きな周期に渡って構造的一体性を維持し、生体適合性の問題に対処し、血液適合性の問題に対処する。加えて、発明は、表面材料の望まれない腰折れ、弁輪内の人工弁の封止の欠如、望まれない繊維の捩り、およびステントへのカバーの取り付け中に弾性から生じる困難さに関する問題点に対処する。
一実施形態では、多数のタイプの組織と生体適合性材料が、ステントの内側の「内部」および/または外側の「外部」側方壁の両方をライニングまたはカバーするのと、一体化封止カフを利用する実施形態をライニングまたはカバーするのに、使われても良いことが構想されている。前述した通り、弁尖コンポーネントは、弁尖アッセンブリーと弁尖を作り出すだめに、追加のワイヤーサポートを使うこと有りかまたは無しで、安定化された組織または合成材料だけから構築されていても良い。この点では、弁尖コンポーネントは、ワイヤーフォームの使用有りかまたは無しで、ステントに取り付けられても良い。
1つの好ましい実施形態では、ステントと合成材料と組織の層化が、様々なオプションで提供されても良い。例えば、1つの好ましい実施形態では、内部層(ステントの内腔内)はDacron (登録商標)(akaPET)であり、ステントの外側外部はここに記載されるように安定化された組織でライニングまたはカバーされることが構想されている。別の実施形態では、Dacron (登録商標)が、ステントの内部と外部上の両方にあり、その一方または両方が、内殖のために必要な微小な「ヘア」を提供するための電気紡糸されたPETであっても良い。別の実施形態では、人工弁が、外部のために組織層の上に合成層を有し、内部上に組織層を有していても良い。
電気紡糸は、ナノからミクロスケールまでの範囲の直径をもったポリマーファイバーを作成する技術である。複雑な形状をもった繊維が、溶液から電気紡糸されることができ、幅広い範囲のファイバーおよび繊維性質を作成する。電気紡糸は、高い表面対重量および容積比をもった材料を作成し、それはそれらの材料を、制御された生物学的相互作用、特に繊維状細胞外マトリクス足場の構築のための優れた候補にする。多くのタイプのポリマーを紡糸する能力と結合された繊維の多孔性の性質は、移植可能な構造の形成を許容する。ここで、人工弁カバー材料は、電気紡糸された繊維を、本体中への一体化を許容するための足場として使うことができ、内殖または細胞付着としても知られる(内皮化とスムーズな筋肉細胞付着の両方)。治療薬から改質剤までの範囲の添加剤が、溶液中に導入されることができ、ファイバーおよび繊維中に組み込まれるようになる。
電気紡糸でポリメリックナノファイバーを作製するために、ポリマーが適切な溶剤中に溶解された。結果として得られた溶液がそれから注射器中に満たされた。注射器ポンプの助けで、溶液が一定の供給レートで、0.21mmの内径をもった針先端を通して排出された。10-15kVの範囲にある高DC電圧(Gamma High Voltage Research, Ormond Beach, FL, USA)が、針と、針の下15cmにあった接地されたアルミニウムプレートの間に印加された。
好ましい実施形態では、超薄の蒸気架橋された安定化された生体補綴または移植組織材料が構想されている。0.003インチ(0.0762mm)から約0.010インチ(0.254mm)を有する組織が、(a)組織標本を、アルデヒド、エポキシド、イソシアネート、カーボジイミド、イソチオシアネート、グリシダルエーテル、およびアクリルアジドからなるグループから選択された架橋剤の蒸気に露出することによって、予備消化された圧縮された組織標本を蒸気架橋するステップと、(b)蒸気架橋された組織標本を、予め決められた時間の間、水性架橋浴槽に露出することによって、蒸気架橋された組織標本を化学的に架橋するステップであって、そのような架橋浴槽は、アルデヒド、エポキシド、イソシアネート、カーボジイミド、イソチオシアネート、グリシダルエーテル、およびアクリルアジドからなるグループから選択された架橋剤の液体相を含んでいるステップ、からなるプロセスを使って作られても良い。[パラ15]そのような組織は、起源が豚、羊、馬または牛であっても良く、好ましくは初期材料は、生後30日以下の牛動物から取られるが、より年取った動物からの組織も発明の範囲内として構想されている。1つの好ましい実施形態では、組織標本は、架橋の前に化学的脱水/圧縮と機械的圧縮に晒される。
弁カラーは、様々なやり方で機能する。人工弁の第1の機能は、生来の弁の代理となることであるが、弁輪と心房の不規則な輪郭に跨って屈曲して封止することによる血液の弁傍漏洩/逆流の阻止のような改良された機能をもつ。
カラーは実質的に平坦で、円形の、バンド形状のカラー構造であり、それは管状ステントに取り付けられてそれを取り囲み、管状ステントの外壁と平坦で円形のバンド形状の環状膨張ガスケットの間に、断面で見られた時に、V字形状を形成する。V字形状のカラー中の取り付けられた(または一体化された)ガスケットの堅いがそれでも柔軟な性質は、人工弁が、弁、例えば、僧帽弁の弁輪中に配備された時に、「コルク」または「シャトルコック」型の構造を確立し、そのばねのようなプッシャーバンドをもったデバイスの楔リング形状が、弁を不動にするように生来の弁輪に対する横方向の環状圧縮圧または力を提供し、人工弁を介して弁機能を再確立するように心臓腔、例えば心房と心室の間の封止を提供する。側方の視点から見られるように、カラー直径は、管状ステントの直径をマッチし、カラーは、心室に最も近くでステントに取り付けられるが、カラーとステント壁がV字形状を形成するので、カラーの直径は、カラーパネルの心房端部においてその最大の直径に達するまで、段々より大きくなる。ここで使われるように、カラー、反転されたフランジ、ガスケット、ばねパネルという用語は、機能的に等価であると考えられる。管状ステントが、左心室の方向にあるテザーループによって、僧帽弁開口、僧帽弁弁輪を通して引っ張られた時に、柔軟なカラーは、管状ステントが僧帽弁開口を通して更に移動することを停止するように働く。この時点で、人工弁全体は、僧帽弁弁輪を通した前進するばね状カラーの強制的な圧縮によって引き起こされた横方向の圧力と、左心室に取り付けられた心室テザーの縦方向の力によって保持される。
作られても良い。
人工弁ステントは、ステントの円周の周りに間隔をおいて位置する一体化されたクランプの使用を通して弁輪内で安定化されることが可能である。このクランプシステムは、金属または同様に硬くて持続可能な材料で作られたクランプを、製造中にステントの一体化されたコンポーネントとして、はんだ付けすることによって、ステントワイヤーをクランプ構造中の係留開口を通すことによって、または同様の取り付けプロセスで、使用しても良い。
心房カフまたはカラーは、様々なやり方で機能する。心房カフ/カラーの第1の機能は、補綴の周りの血液の弁傍漏洩/逆流を阻止することである。弁輪と心房の不規則な輪郭に跨って屈曲して封止することによって、漏洩が最小化されるおよび/または防止される。
心房カフ/カラーは、リムまたは境界を形成するように管状ステントの直径を越えて突出する実質的に平坦なプレートである。ここで使われるように、心房カフ/カラー、カフ、フランジ、カラー、ボンネット、エプロンまたはスカートという用語は、機能的に等価であると考えられる。管状ステントが、左心室の方向にあるテザーループによって、僧帽弁開口、僧帽弁弁輪を通して引っ張られた時に、心房カフ/カラーは、管状ステントが僧帽弁開口を通して更に移動することを停止するカラーとして働く。人工弁全体は、左心房および僧帽弁弁輪に配置されている心房カフ/カラーと、左心室に取り付けられた心室テザーの間の縦方向の力によって保持される。
好ましくは、ニチノール (登録商標)ワイヤーのような超弾性金属ワイヤーが、ステントのために、ステント内に配置された内部ワイヤーベースの弁尖アッセンブリーのために、および封止カフワイヤーフォームのために、使われる。述べられたように、オプションでCu-Zn-Al-Ni合金やCu-Al-Ni合金のようなその他の形状記憶合金を使うことが、発明の範囲内として構想されている。ステントは、組み紐にされたステントとしてかまたはレーザー切断されたステントとして構築されても良いことが構想されている。そのようなステントは、Pulse Systemsのようなあらゆる数の商業的製造業者から入手可能である。レーザー切断されたステントは、好ましくはニッケルチタン(ニチノール (登録商標))から作られているが、また限定無しに、ステンレス鋼、コバルトクローム、チタンおよびその他の機能的に等価な金属および合金、または固定具または心棒上での熱処理によって形状設定されたPulse Systemsの組み紐にされたステントから作られている。
ステントの1つの可能な構築は、薄い、等直径のニチノールチューブのレーザー切断を想定する。レーザー切断は、薄いニチノール(登録商標)チューブ中に規則正しいカットアウトを形成する。二次的に、チューブは、望ましい形状の鋳型上に置かれ、マルテンサイト温度まで加熱されて、冷まされる。このやり方でのステントの処理は、形状記憶特性を有し、カリブレートされた温度において記憶形状に容易に逆戻りする、ステントまたはステ
ント/封止カフを形成する。
ステントは、単純な組み紐化技術を利用して構築されることができる。ニチノールワイヤー、例えば0.012インチワイヤーと単純な組み紐化固定具を使って、ワイヤーは、等直径のチューブが単一のワイヤーから形成されるまで、単純なオーバー/アンダー組み紐化パターンで組み紐化固定具上で巻かれる。ワイヤーの2つの自由端は、その中に自由端が置かれてクリンプされるステンレス鋼またはニチノール結合チューブを使って結合される。約60度の角度付き組み紐が、特に有用であることが見つけられている。二次的に、組み紐にされたステントは、成形固定具上に置かれ、ステントを望ましい形状に設定して、望まれるマルテンサイトまたは超弾性特性を発展させるように、指定された温度におけるマッフル炉中に置かれる。
「一次的MR」は、弁または腱のような関連する組織における解剖学的な欠陥によって引き起こされる僧帽弁逆流を記述する用語である。欠陥は、先天性または退行性のいずれかであり得て、要因にはマルファン症候群から薬物または放射線誘引までの範囲がある。
弁尖は、弁尖アッセンブリーによって、またはその内に、保持される。発明の1つの好ましい実施形態では、弁尖アッセンブリーは、そこに弁尖が取り付けられるところの弁尖ワイヤー-サポート構造からなり、弁尖アッセンブリー全体が、ステント本体内に収容される。この実施形態では、アッセンブリーは、弁尖を取り付けるための好適なプラットフォームを形成するためのワイヤーと安定化された組織で構築される。この側面では、ワイヤーと安定化された組織は、人工弁が配備カテーテル内で圧縮された時に弁尖構造が圧縮されることと、人工弁が配備中に開かれた時に適正な機能的形状に跳ね返って開くことを許容する。この実施形態では、弁尖アッセンブリーはオプションで、安定化された組織または材料で作られた別の円筒状ライナーに取り付けられ、その内に収容されても良く、ライナーはそれからステント本体の内部をライニングするように取り付けられる。
人工心臓弁は、一実施形態では、カテーテルシステムを使って心臓の左心室の心尖を通して心尖的に配送される。心尖的配送の1つの側面では、カテーテルシステムは、肋間配送によって心臓および心膜スペースにアクセスする。別の配送アプローチでは、カテーテルシステムは、柔軟なカテーテルシステムを使い、一般的に使われる硬いチューブシステムを要求すること無しに、順行性または逆行性配送アプローチのどちらかを使って人工心臓弁を配送する。別の実施形態では、カテーテルシステムは、経中隔アプローチを介して心臓にアクセスする。
1つの好ましい実施形態では、心臓内の1つ以上の組織係留位置まで伸びる、人工心臓弁に取り付けられたテザーがある。1つの好ましい実施形態では、テザーは、左心室を通して下向きに伸び、心臓の外側の心外膜表面上に留められるように心臓の心尖において左心室を出る。同様の係留が、三尖弁またはその他の補綴を要求する弁構造に関してここに構想されている。1個から8個のテザーがあっても良く、それらは好ましくはステントに取り付けられる。
一実施形態では、配送システムの心尖進入点における潜在的な組織の切り裂きを制御するために、円形、半円形、またはマルチパートのプレジットが採用される。プレジットは、PFTEフェルトのような半剛性材料から構築されても良い。配送システムによる心尖の穿刺に先立って、心尖が中心的に位置するようにフェルトが心臓にしっかりと取り付けられる。二次的に、配送システムは、プレジットの中心エリア、またはそれがそうであれば開口部、を通して導入される。このやり方で位置決めされて取り付けられると、プレジットは、心尖におけるあらゆる潜在的な切り裂きを制御するように働く。
別の実施形態では、弁は、尖叉またはバーブの使用を通して弁輪内に配置されることができる。それらは、1つ以上のテザーとの関係で、またはその代わりに、使われても良い。尖叉またはバーブは、隣接する組織への取り付けを提供するように位置している。1つの好ましい実施形態では、尖叉はオプションで、ステントと封止カフの間の曲がり/遷移エリアの周りに円周状に位置している。そのような尖叉は、バルーンカテーテルを使ってのような機械的な手段によって、弁輪組織中に強制される。1つの非限定的な実施形態では、尖叉はオプションで、ステントの膨張の際に、弁輪組織を貫通し、その中に回転し、しっかりと保持する、半円形のフックであっても良い。
ばねアンカーが、自己拡張するステントのベースから伸びているばね形状のワイヤーまたはバンドを形成する。アンカーは、生来の弁輪から伸びている腱索の周りに巻き付けられることによって、生来の弁輪内にステントを保持するためのサポートを提供する。アンカーのばね機構は、腱索、弁輪および周囲の組織が収縮し解放するにつれての繰り返しの変形にも拘わらず、人工弁ステントへの一貫したサポートを許容する。コイルの形状記憶特性は、各心臓収縮に応答して各ループが独立して変形して動き、それから心臓が弛緩するにつれて元のコイル寸法に戻ることを許容する。腱索の周りへのコイルの配置は、心臓組織収縮および解放と共に横方向に動き、心室と心房の間の血流と共に縦方向に動くステントの自然な傾向に対抗するようにステントを係留する。
ばねアンカーは、配送システム中への弁およびアンカーアッセンブリー全体の挿入に先立って、溶接、はんだ付けまたは接着を介して、人工弁ステントに融着される。
ばねアンカーは、形状記憶材料、例えば0.012インチニチノールワイヤーの単一のワイヤーまたはバンドであり、一連の2つ以上の円形のループに形成され、その中では近位ループが人工弁ステントのベースに取り付けられる。
ここで図面を参照すると、図1は、本発明による人工弁110の一実施形態を示し、それは、1つの端部にオプションのテザー取り付け構造114を有する管状ステント112からなり、管状ステント112はもう1つの端部において一体化された封止カフ116を提供する。弁尖アッセンブリー118が、ステント112内に配置され、弁尖120をサポートする。封止カフ116は、独立した関節で繋がれたワイヤーのループ122と、内部ライナー/カバー124と、外部ライナー/カバー125を有する。
ここで図面を参照すると、図12は、テザー取り付け構造138を有する管状ステント112とカラー116からなる、本発明による人工心臓弁110の一実施形態を示す。弁尖アッセンブリー118が、ステント112内に配置され、弁尖120(これも図示せず)をサポートする。
ここで図面を参照すると、図21は、ステントベース154に取り付けられたばねアンカー取り付け156を有する管状ステント112からなる、本発明による人工心臓弁110の一実施形態を実証する斜視図描写である。弁尖アッセンブリー118が、ステント112内に配置されている。
テザー138のいくつかは、心膜表面上のプレジット140へのおよびそれを通しての取り付けのために左心室の心尖まで伸びている。テザー138とばねアンカー156は、別々に使われても、ステント112に安定性を提供することとの関係で使われても良い。
図28Aは、外側の周りに位置する4つのクランプ型の環状係留部材160をもったワイヤーステント112の斜視図を示す。図28Bは、同じ4つのクランプ型の環状係留部材160をもったワイヤーステント112の側面図を示す。
ここで図面を参照すると、図46は、心房カフ/カラー116を示し、そこでは形状がいくらかマッシュルーム形状、またはキノコ形である。この実施形態では、血行動態的漏洩が対処され、そこでは心房カフ/カラー116が、病理学的に欠陥のある僧帽弁の交連の輪郭に沿うためにテンショニングまたは下向きばね特徴204を有するように構築されており、病理学的に欠陥のある僧帽弁の癒合ゾーンの輪郭に沿うように構築されている。心房封止ガスケットの各先が下を向いた端部における交連輪郭コンポーネンツと、心房カフ/カラー116の癒合ゾーン輪郭コンポーネンツは、鞍形状に順応するように働き、そこでは交連輪郭コンポーネンツは僧帽弁交連と直接通信しており、癒合ゾーン輪郭コンポーネンツは僧帽弁癒合ゾーンと直接通信している。
ここで図面を参照すると、図63Aは、生来の僧帽弁弁尖のまたは本発明による人工弁尖構造の鞍形状の斜視図である。よって、平坦な二尖弁尖を有する真っ直ぐな管状ステントだけで作られた標準的な人工弁は、あらゆる先行する標準的デバイス上に構造的な、従って機能的な制限を課すことが直ちに明らかとなる。図63Bは、X-Y-Z軸と比較した僧帽弁の3次元相対的位置の図面であり、僧帽弁が軸をはずれて揃えられていることを示す。特定には、僧帽弁は、(より正確な記載については図63Bへの参照がなされる)水平なX軸に沿った中心の左に配置され、X軸の周りを僅かに回転され、それは垂直なY軸に沿った中心の下であり、Y軸の周りを僅かに時計回りに回転され、それはZ軸の周りで僅かに左から右に傾けられ、その全てが大まかに鞍形状である構造中においてである。予め構成された/予め輪郭に沿ったステントの準備に適用されたそれらの教示内容は、本発明の重要な特徴の1つを提供する。
ここで図面を参照すると、図70は、補綴移植無しの生来の僧帽弁218を実証したライン図面である。前部弁尖230、後部弁尖232、前外側交連234、および後部交連236が示されている。前部および後部交連の先端は、参照のために印しが付けられている。
ここに挙げられた文献は、特にそれらがこの技術分野における当業者レベルを教示することに関するので、および請求された発明の主題の平民的理解のために必要なあらゆる開示について、その全体がここに組み込まれる。上記実施形態は変えられ得ること、または発明の範囲から逸脱すること無しに非実質的な変更がなされても良いことが、当業者には明らかであろう。従って、発明の範囲は、以下の請求項とそれらの公平な等価物によって決定される。
Claims (15)
- 心臓の左心房と左心室との間の生来の僧帽弁輪に移植するための人工心臓弁であって、
近位の心房端及び反対側の遠位の心室端を有する、自己拡張する管状ステントと、
前記管状ステント内に配置され、一組の弁尖を支持する弁尖アッセンブリーと、
前記管状ステントに取り付けられて前記管状ステントを取り囲み、前記管状ステントの壁と共に断面においてV字形状を形成するカラーと
を含み、
前記管状ステント及び前記カラーは、前記管状ステントの遠位の心室端のジョイントで結合され、
前記カラーは、前記管状ステントの遠位の心室端から離れて前記管状ステントの近位の心房端に向かって直径が拡大し、
前記人工心臓弁は、前記人工心臓弁の周りに円周方向に配置された複数の尖叉を含み、前記複数の尖叉は、生来の僧帽弁輪に隣接する組織への取り付けを提供するように構成される、人工心臓弁。 - 前記尖叉は、僧帽弁輪の弁輪組織を貫通するように構成された半円形のフックである、請求項1に記載の人工心臓弁。
- 前記カラーは、安定化された組織及び合成材料のいずれかで覆われたニチノール形状記憶材料のウェブから形成される、請求項1に記載の人工心臓弁。
- 前記カラーは、前記管状ステントとは別に形成され、前記ジョイントで前記管状ステントに取り付けられる、請求項1に記載の人工心臓弁。
- 前記カラーはワイヤーのループから形成される、請求項1に記載の人工心臓弁。
- 前記カラーは、ポリエステル繊維材料で形成された、取り付けられたパネルで構成される、請求項1に記載の人工心臓弁。
- 前記カラーは、メッシュ状の表面を提供するように穴が開けられたパネルで構成され、前記管状ステントは、規則的な切り抜きが形成されたチューブで構成される、請求項1に記載の人工心臓弁。
- 前記管状ステント及び前記カラーは、単体のステントカラー構造として一体的に作られる、請求項1に記載の人工心臓弁。
- 前記カラーは、前記人工心臓弁を不動にするべく生来の僧帽弁輪に対する横方向の環状圧縮力を提供するように構成される、請求項1に記載の人工心臓弁。
- 前記管状ステントの内側が組織でライニングされる、請求項1に記載の人工心臓弁。
- 前記管状ステントの外側が、組織又は合成材料のいずれかでライニングされる、請求項1に記載の人工心臓弁。
- 前記弁尖アッセンブリーは牛心膜組織で形成される、請求項1に記載の人工心臓弁。
- 前記カラーは、生来の僧帽弁輪の形状の不規則性に適合することができる、請求項1に記載の人工心臓弁。
- 前記カラーは、前記人工心臓弁の周りに血液が漏れるのを防ぐために、生来の僧帽弁輪内の組織に対して緊密な封止を提供するように構成される、請求項13に記載の人工心臓弁。
- 前記人工心臓弁は、テザーを使用せずに前記複数の尖叉によって生来の僧帽弁輪に固定されるように構成される、請求項14に記載の人工心臓弁。
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