JP7094965B2 - 心臓弁模倣 - Google Patents

心臓弁模倣 Download PDF

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JP7094965B2
JP7094965B2 JP2019539781A JP2019539781A JP7094965B2 JP 7094965 B2 JP7094965 B2 JP 7094965B2 JP 2019539781 A JP2019539781 A JP 2019539781A JP 2019539781 A JP2019539781 A JP 2019539781A JP 7094965 B2 JP7094965 B2 JP 7094965B2
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prosthesis
valve
stent
end region
cell
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サファリ、パヤム
ミン ハイ チョウ、ビンセント
ルルド、マケンスレー
エス． ラングワーラ、フセイン
エドウィン ミリガン、グレゴリー
エフ． ミグリアッツァ、ジョン
イー． カー－ブレンデル、ビクトリア
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イエナバルブ テクノロジー インク
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Description

本開示は、心臓弁狭窄（ｓｔｅｎｏｓｉｓ，ｎａｒｒｏｗｉｎｇ）及び／又は心臓弁閉鎖不全の経カテーテル治療に有用なステント支持置換心臓弁に関する。
本開示はまた、従来技術の心臓弁から知られているような干渉及び副作用がより少ない、いくつかの態様で内在心臓弁を解剖学的に位置決め及び模倣するように設計された体内プロテーゼ（プロテーゼ）にも関する。
詳細には、本開示はまた、心臓弁狭窄及び／又は心臓弁閉鎖不全の治療用の、カテーテルを用いて移植部位に送達されることができるステントを組み込んだ折畳み可能かつ拡張可能なプロテーゼにも関する。
「心臓弁狭窄及び／又は心臓弁閉鎖不全」という表現は、遺伝的なものであるか又は発現したものである、１又は複数の心臓弁の機能的欠陥を含み得る。このタイプの心臓欠陥は、４つの心臓弁のそれぞれに影響を及ぼす可能性があるが、左心室の弁（大動脈弁及び僧帽弁）が心臓の右心部（肺動脈弁及び三尖弁）よりも影響を受けることがはるかに多い。この機能的欠陥は、結果的に狭窄、閉鎖不能（閉鎖不全）、又はこの２つの組合せ（複合異常）をもたらすことがある。本開示は、こうした心臓弁欠陥を治療するための、患者の体内に経腔的に移植可能であり、経皮的に又は任意の他の既知の低侵襲的方法で導入された後に半径方向に拡大又は半径方向に自己拡張することが可能な拡張型ステントを含む体内プロテーゼに関する。
心臓弁の重度の狭窄及び／又は心臓弁閉鎖不全の治療によっては、狭窄又は罹患した心臓弁が体内プロテーゼに置換されることもある。この目的のために、典型的には罹患した心臓弁の除去後に胸部の開口を通って心臓弁ベッドに外科的に縫い付けられる生体弁又は機械弁モデルが用いられる。この手術は、処置中に患者の循環を維持する人工心肺装置を使用する必要があり、プロテーゼの移植中に心停止が誘発される。これは、患者にとっての関連する危険、並びに長い術後治療及び回復期を伴う、リスクのある外科的処置である。こうした手術は、多病の（ｐｏｌｙｐａｔｈｉｃ）患者の場合に正当なリスクがあると見なされないことが多い。
低侵襲の治療形態が過去１０年間にわたって開発されており、これらは、局所麻酔下で処置を行うことを可能にすることを特徴とする。１つの手法は、カテーテルシステムを用いて、例えば心膜組織から作製された折畳み可能弁が接続された自己拡張型ステントを移植する。こうした自己拡張型体内プロテーゼは、カテーテルシステムを介して心臓内の移植部位に鼠径動脈又は静脈を通って誘導されることができる。移植部位に到達した後、次いでステントが解放され、自己拡張することが可能になることができる。
ステントは、例えば、複数の自己拡張長手方向ステントセグメントを含んでもよく、これらのセグメントは互いに連接されている。心臓に近い適当な血管内の所定の位置にステントをしっかりと固定するために、血管壁と係合するように固定バーブが用いられてもよい。
体内プロテーゼの締結及び固定用の拡張型ステントが、独国特許第１００１００７４号明細書から知られており、このステントは針金状の相互接続されたセグメントから本質的に形成されている。独国特許第１００１００７４号明細書は、体内プロテーゼを締結及び固定するための、移植部位で弁プロテーゼを締結及び支持する機能を呈する異なるアーチ形要素を有するステントを提案している。具体的には、それぞれ互いに１２０°間隔の３つの同一に構成された位置決めアーチが使用される。これらの位置決めアーチは、固体関節によって互いに接続されている。位置決めアーチに加えて、補足的湾曲保持アーチが、ステントの展開に続いて血管壁を半径方向に圧迫することによって体内プロテーゼを固定する働きをする。
一方では、従来技術の処置及びプロテーゼ設計は、低侵襲アクセス及び留置処置の利便性を重視する。他方では、既知のプロテーゼ設計は、留置時の弁機能、例えばステントへの弁縫合の耐久性に焦点を合わせている。他の態様は、心臓が拍動しているときに、例えば、そのかなりの力が心周期の充満期（拡張期）中に体内プロテーゼに作用するが、プロテーゼがその位置にとどまり得るかどうか、またこれがステントに対して長手方向の体内プロテーゼ変位につながることがあるかどうかという疑問に関する。従来技術の別の焦点は、弁周囲漏出を回避するために確実な封止をもたらす態様であった。さらに、過去においては、冠動脈口（冠動脈の入口オリフィス）の閉塞を回避するような位置決め態様と、プロテーゼのこうした干渉が致命的な冠動脈虚血及び心筋梗塞につながることがあるという事実とが認識されていた。
しかし、従来技術の手法及び解決策は、移植処置、基本的な弁機能、及び漏出の態様に焦点を合わせている。こうした経カテーテル心臓置換処置の即時及び長期の副作用、並びに内在心臓弁を模倣することについては、全く対処されておらず、又は述べられているとしても、この態様は従来技術によって十分に対処されていない。
さらに、現在の経大動脈弁置換術（ＴＡＶＲ）及びこの処置に使用される既知のデバイスは、発作率の上昇（約４～６％）、又はデバイスに応じて２５％までの治療患者へのペースメーカ移植の必要性のような、いくつかの欠点及びリスクを伴う。これらの問題は、既知のデバイスでは十分に対処又は解決されていない。
さらに、従来技術は、こうした治療の機能的影響、ペースメーカ率などの移植の副作用、及び長期の処置後の影響に関して、並びに持続可能な長期有効性に関して、心臓弁置換術の全体の複雑性を理解していない。
従来技術の手法の一課題は、プロテーゼが内在心臓弁を十分に模倣しておらず、したがって、従来技術のプロテーゼの移植が、結果的にいくつかのレベルで患者の心臓及び内在心臓機能との干渉、並びに心臓弁置換術の耐久性への潜在的に不利な影響及び望ましくない長期副作用をもたらすことである。したがって、既知の経カテーテル心臓弁治療は、患者にとって充分な長期的解決策となっていない。
上記に概略説明した課題に鑑み、本願のある特定の実施形態の一目的は、患者への移植時の副作用が軽減した経カテーテル心臓弁プロテーゼを提供すること、又は少なくとも従来技術の欠点を軽減若しくは回避することである。
本願のある特定の実施形態の別の目的は、患者の心臓の体内機能との低減した干渉若しくは実質的に最小限の干渉を示す経カテーテル心臓弁プロテーゼを提供すること、又は少なくとも従来技術の欠点を軽減若しくは回避することである。
本願のある特定の実施形態の別の目的は、患者の長期耐久性のある経カテーテル心臓弁治療となる構造的特徴を示す経カテーテル心臓弁プロテーゼを提供すること、又は少なくとも従来技術の欠点を軽減若しくは回避することである。
一態様では、本開示は、改善されたプロテーゼ位置合わせ特性を有し得る心臓弁置換プロテーゼに関する。
別の様態では、本開示は、交連及び弁輪位置合わせ手段を備える心臓弁置換プロテーゼに関する。
別の様態では、本開示は、単独で又は組み合わせて、内在心臓弁のより優れた模倣を行い得、患者の心臓とのより少ない干渉につながり得る以下の特徴のうちの１又は複数を備える心臓弁置換プロテーゼに関する。
１．ｃｍ２面積当たりのセル数が、流入端領域では２～６、より好ましくは３．７～５．１、流出端領域では１～４、より好ましくは１．９～２．５である。又は／及び
２．流入端領域では、任意の所与のセルの隣接するセルに対する面積比が０．２５～４、より好ましくは１である。又は／及び
３．流入端領域では、任意の所与のセルの隣接するセルに対する高さ比が０．５～２、より好ましくは１である。又は／及び
４．流入端領域では、全てのセルのアスペクト比が１～２、より好ましくは１．５～１．６である。アスペクト比は、セルの高さの幅に対する比と定義され得る。又は／及び
５．流出端領域では、セルのアスペクト比が１～３、より好ましくは１．１～２．９の範囲である。アスペクト比は、セルの高さの幅に対する比と定義され得る。又は／及び
６．流出端領域では、単一の円周方向列内でセルの面積が異なり、円周方向列内の隣接するセルの面積が５～２５０ｍｍ２、より好ましくは７～１９８ｍｍ２の範囲である。又は／及び
７．流出端領域では、単一の円周方向列内でセルの高さが異なり、円周方向列内の隣接するセルの高さが３～３０ｍｍ、より好ましくは６ｍｍ～２５ｍｍの範囲である。
別の様態では、本開示は、有利な血行動態を示し、自己弁機能の自然の血行動態を模倣又は本質的に模倣し得る、心臓弁置換プロテーゼに関する。
別の様態では、本開示は、置換心臓弁プロテーゼの移植方法に関する。
別の様態では、本開示は、罹患若しくは狭窄した心臓弁、又はそうでない場合は機能不全の心臓弁の治療方法に関する。
図１は、本開示のある特定の態様において関連する弁輪径（１１）及び弁輪と交連との間の距離（１２）を図示する。 図２は、有利な位置合わせ及び自然心臓弁の模倣を示し得る本開示の例示的な実施形態に対する弁輪径（ＡＤ）及び弁輪と交連との間の距離（ＡＣＤ）関係を有する内在心臓弁を図示する。 図３は、近位端に配置された交連位置合わせ手段を有する例示的なプロテーゼの上面図及び側面図を図示する。 図４は、近位端に配置され、図３の設計の変形形態となる交連位置合わせ手段を有する、別の例示的なプロテーゼを図示する。 図５は、内在心臓弁に設置された本開示の例示的なプロテーゼを図示し、完全に機能的な内在心臓弁の自然の血行動態を本質的に模倣し得る血行力学的血流を示す。
本明細書で使用されるとき、「備える」、「備えている」という用語、又は他のその変形形態は、要素の一覧を備えるプロセス、方法、物品、若しくは装置がそれらの要素しか含まないのではなく、明示的に列挙されていない、又はこうしたプロセス、方法、物品、若しくは装置に固有の他の要素を含み得るように、非排他的な包含を含むことを意図するものである。その上、本明細書で使用される「例示的な」という用語は、「理想」ではなく「例」の意味で使用されるものである。
本明細書で使用されるとき、「約」、「実質的に」、及び「およそ」という用語は、記載値の＋／－５％以内の値の範囲を示し得る。
従来技術の少なくともいくつかの課題は、ステント構成要素及び弁構成要素を備える置換心臓弁プロテーゼであって、約１．０１～１．１４、好ましくは約１．０３～１．０４の、弁輪と交連との間の距離の弁輪径に対する弁比、又は／並びにｃｍ２面積当たりのセル数が、流入端領域では約２～６、より好ましくは３．７～５．１、流出端領域では約１～４、より好ましくは１．９～２．５であること、又は／並びに前記流入端領域では、任意の所与のセルの隣接するセルに対する面積比が約０．２５～４、より好ましくは約１であること、又は／並びに前記流入端領域では、任意の所与のセルの隣接するセルに対する高さ比が０．５～２、より好ましくは１であること、又は／並びに前記流入端領域では、全てのセルのアスペクト比が約１～２、より好ましくは約１．５～１．６であること、又は／並びに前記流出端領域では、セルのアスペクト比が約１～３、好ましくは約１．１～２．９の範囲であること、又は／並びに前記流出端領域では、単一の円周方向列内でセルの面積が異なり、円周方向列内の隣接するセルの面積が約５～２５０ｍｍ２、好ましくは約７～１９８ｍｍ２の範囲であること、又は／並びに前記流出端領域では、単一の円周方向列内でセルの高さが異なり、円周方向列内の隣接するセルの高さが約３ｍｍ～３０ｍｍ、より好ましくは約６ｍｍ～２５ｍｍの範囲であること、又は／並びに半径方向力の約１５～２５％が弁輪領域によって与えられ、半径方向力の約７５～８５％が弁輪上領域によって与えられる、前記プロテーゼ及び前記ステントの半径方向力分布、又は／並びに交連位置合わせ手段の近位端と流入端セクションの遠位端との間の距離が、４～１２ｍｍ、好ましくは７．５～９ｍｍであることを特徴とする、置換心臓弁プロテーゼによって解決され得る。
本開示のある特定の実施形態の一利点は、これらが前記プロテーゼの交連を自己弁交連と位置合わせする手段を提供することである。この利点は、自己弁ポケット内に突出する位置決め手段により、又は自己交連への自己位置合わせによって位置合わせを実現する位置決め手段によって達成され得る。したがって、前記位置合わせ手段は、それぞれの目的のために必要に応じて、前記プロテーゼに取り付けられているか、又は前記プロテーゼの一部であり、例えば、自己弁ポケット内若しくは自己交連に配置されるものであり、したがってこれらの手段は前記プロテーゼの本体からある距離若しくは長さ突出しており、あるいはこれらは、自己交連に直接嵌合する前記プロテーゼの位置合わせ手段となり得る。
本開示のある特定の実施形態の別の利点は、前記ステントが、狭窄のリスクを軽減又は本質的に完全に回避するように設計されていることである。大動脈弁狭窄を有する患者については、弁輪上領域、特に弁尖が最も罹患した部分であり、狭窄が主にこの領域内及び周囲に生じることがＴＡＶＲ処置で示されている。本開示の少なくとも１つの実施形態は、この点においてその特有の設計によって１つの解決策を提供する。前記プロテーゼの心膜弁を支持する前記ステントは、ＴＨＶの長さに沿って識別的長期外向き力（ＣｏＦ）を有し得る。これは、最も外向きの力を罹患した部分、例えば弁輪上領域に、より低い外向き力を自己血管の弁輪領域に本質的に与え得る。狭窄が主に弁輪領域ではなく弁輪上領域の弁尖に生じるので、これは有用であり得る。
本開示で説明するステントの設計及び幾何形状は、弁輪領域によって与えられる約１５～２５％の半径方向力、及び弁輪上領域によって与えられる約７５～８５％の半径方向力という半径方向力分布を実現し得る。
本開示のある特定の実施形態の別の利点は、前記プロテーゼの特有の設計が、純粋な交連位置合わせを越えて解剖学的位置合わせを提供し得ることである。したがって、本開示のある特定の実施形態で説明する自己弁との前記プロテーゼの構造的位置合わせは、従来技術の置換心臓弁に比べてより少ない副作用で、内在自己弁と同様又は本質的に同様の血流動態を維持し得る。
本開示のある特定の実施形態の利点は、一態様では、ストラット設計、ストラット寸法、及びストラット分布によって達成され得る。
本開示のある特定の実施形態の利点はまた、一態様では、ステントセル密度、及び前記ステントの異なるセクション内のステントセル分布によっても達成される。前記ステントの遠位端にある流入端領域は一般に、心室内で弁輪の下方に位置し、流出端領域は一般に、前記ステントの近位端に弁輪の上方に位置する。両方の領域は、本開示の有利な機能的態様に寄与し得る特有のステントセル又は／及び物質分布を示す。
別の利点は、前記プロテーゼが、一態様では、本質的に内在交連及び弁尖とのプロテーゼ弁交連及び置換弁の「円周方向位置合わせ」を行うことである。これは、円周方向位置合わせに対して自然弁機能性を維持し得、血流パターンの任意の潜在的な変化による望ましくない副作用を最小限にするか又は排除することに関連し得る。本開示に関する「円周方向位置合わせ」は、自然交連へのプロテーゼ交連の位置合わせに関し得る。「軸方向位置合わせ」は、内在弁との置換弁の垂直レベルの位置合わせに関し得る。置換交連及び弁の両方の、それらの内在対応物との必要不可欠な円周方向及び軸方向の位置合わせを実現し得る。したがって、こうした構造的位置合わせは、前記置換心臓弁プロテーゼの移植後、及び自然心臓弁機能に似ておりこれを本質的に模倣する心機能中に、血流動態及び圧力分布を実現し得る。
別の利点は、本開示で説明するプロテーゼが、自己大動脈弁の血行力学的特性を再現し得ることである。自己弁尖の高さとの人工弁尖の高さの位置合わせと組み合わされた交連の円周方向位置合わせは、結果的に自己弁と同様の方法及び位置で人工弁の開閉をもたらし、それによって自己弁の自然の血流動態を維持し得る。また、前記プロテーゼは、大動脈基部洞をステントフレーム又は組織で閉塞せず、弁が閉じたときに血液が部分内で自由に流れることを可能にし、またこの領域内での渦流の自然形成と干渉することがない。
図１は、弁輪径寸法（水平矢印）、及び内在弁輪と上部交連縁部（近位内在交連縁部）との間の距離（垂直矢印）を図示する。本開示は、上行大動脈又は左心室などの心臓部分に前記プロテーゼを延ばすことなく、体内寸法を模倣するために位置合わせ及び相対的位置決めを実現する。有利には、前記プロテーゼは、内在機能部分又は機能的に重要な部分との干渉を回避し得、弁周囲漏出や永久ペースメーカ移植の必要性などの、ＴＡＶＲ処置から生じる問題又は複雑化をも回避し得る。
「大動脈弁閉鎖不全」又は略して「大動脈閉鎖不全」という用語は、心臓の大動脈弁の閉鎖不良、及び結果として大動脈から左心室への血液の拡張期逆流を指し得る。大動脈閉鎖不全の重症度及び大動脈劣化に対する抵抗力の度合いに応じて、逆流量は左心室の駆出量（正常な心拍出量４０～７０ｍｌ）の３分の２までになる可能性がある。これは、結果的に特徴的に高い血圧振幅をもたらす。この逆流した血流は、左室の拡張期充満を増加させ、心臓のこの区画の容量過負荷につながり、その結果が遠心性肥大である。
本開示のいくつかの実施形態に寄与し、有利に寄与し得る構造的特徴は、内在弁尖の幾何形状とのＴＨＶプロテーゼ弁尖の位置合わせ、並びに／又は内在弁交連とのＴＨＶ交連の位置合わせ、並びに／又はＴＨＶの長さにわたるＴＨＶステントセルのサイズ、例えば、弁輪領域におけるより高いセル密度及び流出領域におけるより低いセル密度である。
別の様態では、前記プロテーゼの有利な結果に寄与する構造的特徴は、交連位置合わせ手段、組織締結部、及び内在弁尖幾何形状とのプロテーゼ位置合わせ、並びに前記交連位置合わせ手段と前記ＴＨＶの遠位端との間の遠位距離である。
好ましい実施形態では、本開示は、ステントが少なくとも１つの位置合わせ手段、好ましくは２つ、３つ、４つ、５つ、又は６つの位置合わせ手段をさらに備える、上述のようなプロテーゼに関する。
別の様態では、本開示のプロテーゼは、前記位置合わせ手段が、１若しくは複数の自己弁尖内に導入されるフィーラであるか、又は／及び１若しくは複数の自己弁交連と係合する交連位置合わせ手段であり、前記プロテーゼの近位端の一部であるか又はこれに固着されていることを特徴とする。
別の様態では、本開示のプロテーゼは、前記ステントが弁組織、好ましくは心膜組織の固着用の締結部をさらに備えることを特徴とする。好ましくは、前記締結部はアーチであり、好ましくは穴又はレール又はノッチを備える。
別の様態では、本開示は、心臓弁狭窄又は心臓弁閉鎖不全の治療における本明細書で説明するようなプロテーゼの使用に関する。
別の様態では、本開示は、本明細書で説明するような予め装着されたプロテーゼを血管留置に有用な送達カテーテルで装着又は使用する工程と、前記カテーテルを患者の血管系に導入する工程と、前記プロテーゼを標的部位で留置するために前記カテーテルを突出させ位置決めする工程と、前記プロテーゼを前記標的部位で解放及び留置する工程と、前記カテーテルを前記患者の血管系から後退させる工程とを含む、心臓弁狭窄又は心臓弁閉鎖不全の治療方法に関する。
特に利点があるのは、本開示のいくつかの実施形態によるプロテーゼの特有の幾何形状であり、これが結果的に既知の置換心臓弁に比べてより少ない移植後の副作用をもたらし得る。
前記プロテーゼは、優れた長期機能性及び／又はより少ない副作用につながり得るステント及びプロテーゼ設計に関する以下の有利な特徴を特徴とし得る。本開示で説明するプロテーゼは、組み合わされた以下の特徴のいくつかのうちの１つを示し得る。
一態様では、ステント機構及びセクションの「寸法」、及び互い（ひいては弁支持を含むプロテーゼ）に対する相対比率は、患者において所望のプロテーゼ機能を模倣及び実現し、望ましくない副作用を軽減又は本質的に回避することに関連する。
本開示によるプロテーゼを様々なセクションに分割／画定することができる。一態様では、前記プロテーゼは、軸方向に構成されることができ、この場合、前記プロテーゼは、フレームセクションの遠位端に流入端領域を、フレームの近位端に流出領域を有する。
文献によれば、弁輪と交連との間の距離（ＡＣＤ）の弁輪径（ＡＤ）に対する比は、典型的には０．８５～１．１４、患者の平均では１．０４である（Ｈ．Ｒｕｅｌ ｅｔ．ａｌ．１９９０）。
本開示で説明するプロテーゼの設計及び幾何形状は、自己弁の弁輪径に応じて、約１．０１～１．１４、好ましくは１．０３～１．０４の、弁輪と交連との間の距離の弁輪径に対する弁比を実現し得る。図２にも詳細が示してある。
別の態様は、前記ステントの環状幾何形状が近位セクションの幾何形状から独立していることである。内在弁の幾何形状では、弁輪は一般に非円形であり、交連領域は円形である。その移植状態では、流入端領域における前記プロテーゼの前記ステントは非円形幾何形状を維持し、一方、流出領域の近位端は円形幾何形状を維持する。前記ステントは、流出端領域の高さ、又は上述のＡＣＤ（弁輪と交連との間の距離）とＡＤ（弁輪径）との比によって、これを実現する。
別の様態では、前記プロテーゼは水平方向に、例えば、２～３回繰り返され得る２つのセクションにも構成されることができる。
別の態様は、全体として、又は上述のような異なるセクションに関して、「円周方向ステントセル分布」又は「隣接するセルの円周方向部分被覆」である。
本開示によるセル分布は、様々なパラメータ及び特徴によって定義されることができる。自己弁の直径に応じた、移植後に有利な構造的及び機能的な性能特性を生じるセル分布特徴は、以下のうちの任意の１又は複数を含む。
セル密度、又はｃｍ２面積当たりのセル数が、流入端領域では約２～６、好ましくは３．７～５．１、流出端領域では約１～４、好ましくは１．９～２．５とすることができる。
流入端領域では、任意の所与のセルの隣接するセルに対する面積比が約０．２５～４、より好ましくは約１である。
流入端領域では、任意の所与のセルの隣接するセルに対する高さ比が０．５～２、より好ましくは１である。
流入端領域では、全てのセルのアスペクト比が１～２、好ましくは１．５～１．６である。アスペクト比は、セル高さのセル幅に対する比と定義され得る。
流出端領域では、セルのアスペクト比が約１～３、より好ましくは約１．１～２．９の範囲である。アスペクト比は、セル高さのセル幅に対する比と定義され得る。
流出端領域では、円周方向列内の隣接するセルの面積が約５～２５０ｍｍ２、好ましくは約７～１９８ｍｍ２の範囲である。
流出端領域では、円周方向列内の隣接するセルの高さが約３～３０ｍｍ、好ましくは約６ｍｍ～２５ｍｍの範囲である。
本開示によるプロテーゼのステント（ＴＨＶ若しくはプロテーゼフレーム、又は支持フレーム）は、留置後に大動脈弁輪及び大動脈基部壁に半径方向力を加え得る。この半径方向力が、前記プロテーゼを正しい位置に保つ主な要因であり得る。大動脈基部／弁輪と前記ステントとの間の摩擦力は、前記ステントの半径方向力に起因し得、一方、前記フィーラは各フィーラ先端と自己大動脈弁尖との間に機械的干渉を生じる。
本開示の別の態様は、前記交連位置合わせ手段の近位端と流入端セクションの遠位端との間の距離であり、これは、流入端領域の最終的な高さ及び位置が、永久ペースメーカ移植の必要性を防止するように弁輪内で適切な高さにあることを確実にするのに重要である。本開示の特定の一実施形態では、この距離は４～１２ｍｍ、最も好ましくは７．５～９ｍｍである。
別の態様は、前記プロテーゼの近位端に配置された交連位置合わせ手段であり、これは、１つ、２つ、又は３つの手段とすることができる。これは、弁の内在交連との係合を可能にし、前記プロテーゼが遠位方向に（心室に向かって）軸方向移動するのを防止し、前記プロテーゼを内在交連と位置合わせするように形成されており、それによって体内解剖学的位置合わせを模倣する。先に開示した前記プロテーゼ及び前記ステントの寸法的特徴と組み合わせて、この近位交連位置合わせ手段はまた、内在弁の位置に従った弁の遠位流入端領域の垂直方向位置決めをも可能にし得る。この目標は、あるいは、それに応じて適合された先に開示した前記ステントの寸法的特徴と組み合わせて、ステントの一体部分に取り付けられた又はこれを形成する（１つ、２つ、又は３つの）位置合わせ手段によって達成されることができる。図３には例示的な実施形態が示してある。
本開示の体内位置決めは、前記プロテーゼの正しい位置決めのために、前記プロテーゼに付けられた可視マーカを用い、留置処置中にこれらを監視することによって実現されることができる。本開示によるいくつかの実施形態にとって特に有用であるのは、上述及び後述のような位置合わせ手段とすることができる。
本明細書で説明するように、ステントは、血管内に、好ましくは経大腿的に移植可能であって、経皮的に導入された後に半径方向に拡大又は自己拡張可能な、半径方向拡張型血管内インプラントであってもよい。前記ステントは、心拍動下経心尖処置又は逆行性経大動脈処置などの低侵襲アプローチを用いて、狭窄した自己大動脈弁又は肺動脈弁などの患者の罹患した自己弁に設置されるように構成され得る。ステントは、任意の数のアクセスポイントを経由して患者の体内に導入されることができるが、大動脈弁への大腿部アクセス又は経心尖アクセスによる経血管アプローチが好ましい。しかし、本開示はこれらのアプローチに限定されるものではない。
「自己大動脈弁」は、３つの弁尖を有する弁であってもよく、又は２つの弁尖を有する先天性二尖弁であってもよい。
体内プロテーゼには、（弁プロテーゼが取り付けられたステントと共に）逆止弁として機能するインプラントが含まれ得、順方向の血流を可能にするために開き、逆流を防止するために閉じる。弁プロテーゼは、少なくとも２つ、好ましくは３つの弁尖と、前記弁尖が接続された弁スカートとからなってもよい。
少なくとも１つの締結部が、前記ステントの長手方向軸に沿って延び、前記少なくとも１つの締結部の長さに沿って離散位置に長手方向に分布した複数の締結穴を備える。各締結穴を通って糸又は細いワイヤが誘導されて、前記弁プロテーゼを前記ステントに固定し得る。この特徴の一利点は、ひとたび移植されると、前記ステントに対する弁の長手方向変位が実質的に最小限に抑えられ、したがって前記プロテーゼが心臓の蠕動運動の結果として過度に阻害又は脆弱化されないことであり得る。
その上、前記ステントは、穴を含む締結手段を含んでもよく、及び／又は縫合材料の収容及び保持に役立つ１又は複数のノッチを含んでもよい。ノッチはまた、前記ステントへの、同様に前記締結穴への前記プロテーゼの均一な取付けにも役立ち、前記プロテーゼの長手方向変位を最小限に抑え得る。
１対の締結部から及びこれらの間には締結アーチが延び、これに弁組織が取り付けられるか、又は弁組織がかぶせられる。前記ステント及びこれに取り付けられた弁プロテーゼの拡張及び移植状態では、前記ステントの前記締結アーチは、漏出に対して封止するために、少なくとも前記ステントの下部セクションで血管壁に当接する。さらに、前記締結アーチを用いて、プロテーゼ組織が前記ステントの他の部分から離れるように分離及び保持され、それによってこれらのステント部分が組織を切り、これがさらには結果的に前記プロテーゼの損傷及び脆弱化をもたらす可能性が低下する。
前記ステントは、自然交連との前記プロテーゼの弁の位置合わせを助ける、前記ステントの一体部分であるか又は前記ステントの適当な位置でこれに取り付けられた位置合わせ手段を備えてもよい。こうした手段は、自然大動脈弁の１又は複数の弁尖に配置された少なくとも１つのフィーラ、又は可能な２つ若しくは３つのフィーラであってもよい。こうした位置合わせ手段はまた、交連位置合わせを可能にする交連位置合わせ手段であってもよい。これは、前記交連位置合わせ手段自体を内在交連の近位に位置合わせし、及び／又は内在交連の近位部と係合し、それによってプロテーゼ交連を内在交連と位置合わせすることによって実現されることができる。このようにして、前記プロテーゼの交連は、患者の心臓内で自然交連と位置合わせされて配置され得る。
移植形態では、前記ステントの少なくとも１つの位置合わせ手段が、前記ステントの外周から概して半径方向に延びる。
本開示の特定の実施形態による弁プロテーゼに使用されるステントの製造に際しては、前記ステントは、管の一部から、特に金属管から一体的に切り出された構造を示し得、これは、前記ステントの全ての構成要素を組み込む。前記ステントが、比較的大きい管、例えば、最終的なステントのその折畳み形態における直径に比べて直径が大きい管から切り出されることも考えられる。例えば、直径がおよそ１０ｍｍの管が、特有のステントパターンをこの管に切削するために使用されてもよい。その場合には、前記ステントを、最初に切り出されたものよりも小さいものにクリンプすることが必要になるので、カットパターンは異なり得る。具体的には、この手順を用いて、定められた方法で切削及び加工中に材料を除去し、それによって最終的なステントの機能性を強化することが可能である。
前記ステントは、第１の予め定義可能な形状から第２の予め定義可能な形状に変形することができる一体形成された構造を示すことが好ましく、それにより、前記ステントが、患者の体内への挿入中に第１の予め定義可能な形状（折畳み形状）を、ひとたび移植されると第２の予め定義可能な形状（拡張形状）を示す。
好ましい実施形態では、前記ステントは、その第１の形状（折畳み形状）において、およそ４～８ｍｍの外径、及び３０ｍｍ～４８ｍｍの長さを示す。より正確には、前記ステントは、その第１の形状（折畳み形状）において、およそ４．０～８．０ｍｍ、好ましくは６．０～６．７ｍｍの外径、及び３３．０ｍｍ～４５．０ｍｍ、好ましくは３６．０ｍｍ～４２．０ｍｍの長さを示してもよい。これにより、例えば１９Ｆ又は２１Ｆデリバリシステムを用いて、前記ステントを含むプロテーゼを患者の体内に容易に挿入し、直径が１９ｍｍ～２８ｍｍの体内プロテーゼと共に使用することが可能になる。上述の長さ仕様は現在好ましい寸法であり、これに基づいて、前記ステントが治療を受ける患者の大部分に適したものになる。
特に好ましい実現形態では、前記ステントは、弁プロテーゼ、好ましくは生体弁プロテーゼ又は心膜弁プロテーゼであって、前記弁プロテーゼの１又は複数の組織構成要素が、糸などによって前記ステントの少なくとも１つの締結部に取り付けられている弁プロテーゼを備える。交連位置合わせ手段も好ましいプロテーゼの一部を形成しており、より好ましい実施形態では、前記位置合わせ手段は交連及び弁輪位置合わせにつながり得る。
一実現形態では、前記ステント、ひいては前記プロテーゼは、有利な半径方向コンプライアンスを示す。上記で定義されたような前記ステントの３つのセクションは、それぞれセクション１から２、３へと、又はセクション１から２へと、様々な弾性を有し得る。流入端領域（セクション１）は、相対的に低い弾性及び相対的に高い剛性を示し得る。セクション２（前記プロテーゼを２つのセクションに分けるとき）は、より高い弾性及びより低い剛性を示し得る。前記ステントが３つのセクションに分かれている場合、セクション１からセクション２、セクション３へと勾配が存在する。
さらに、有利なステント設計は、心臓が拍動しているときの内在弁挙動を模倣することを可能にし得る。本開示のこの態様の１つの設計特徴及び利点は、前記プロテーゼの弁輪部分（又は流入端領域）が本質的にその直径を維持することである。近位セクション（それぞれセクション２、又はセクション２及び３）は、それらのより高い弾性のため、運動を可能にし得る。このようにして、弁の交連、及び前記ステントの（ひいては前記プロテーゼの）全体直径が、弁が閉じたときに内向きに移動可能であり、セクション３の直径（又はそれぞれセクション２）が減少し、それによって内在自己弁を模倣し得る。このようにして、移植されたときの前記プロテーゼの流入端は、自然な体内機能性に似ていることがあり得、この場合、直径が本質的に一定のままであり、近位プロテーゼセクションがその直径を変化させ、弁が閉じたときにその直径を減少させる。近位端の直径は、１～３ｍｍ、又は１～２ｍｍ減少することができる。
前記ステント用の材料としては形状記憶材料が使用されることが好ましく、この材料は、前記ステントが外部刺激の影響下で一時的形状から恒久的形状に変形することができるように設計されている。それによって、一時的形状は前記ステントの第１の形状（例えば、前記ステントの折畳み状態）であり、一方、恒久的形状は前記ステントの第２の形状において（例えば、前記ステントの拡張状態において）とられる。具体的には、例えばニッケルとチタンとの等原子合金であるニチノールなどの形状記憶材料を使用すると、前記ステントの移植時に特に穏やかな移植処置が可能になる。
製造時には、前記ステントは、形状記憶材料から作製されることが好ましく、ステント構造は、管から切り出された後に成形されることが好ましい。前記ステントが、最終的なステントのその折畳み形態における直径に比べて直径が大きい管から切り出されることが考えられる。その場合、レーザ加工された管がクリンプされ、それによって前記ステントのその折畳み形態における直径を実現する。ひとたび所望の形状が形成されると、この形状は「固定」され、このプロセスは「プログラミング」として知られている。プログラミングは、ステント構造を加熱し、前記ステントを所望の形状に形成し、次いで前記ステントを冷却することによって行われ得る。プログラミングは、ステント構造をより低い温度で形成及び成形することによっても行われ得、これは「冷延伸」として知られている。このようにして恒久的形状が保存されて、前記ステントを一時的な未形成形状で保管及び移植することが可能になる。次いでステント構造に外部刺激が作用する場合、形状記憶効果が発現し、保存された恒久的形状が復元される。
特に好ましい実施態様は、定義可能な変態温度である外部刺激を与える。したがって、形状記憶効果を発現させ、それによって保存された恒久的形状を回復させるために、ステント材料を変態温度よりも高い温度まで加熱する必要があることが考えられる。形状記憶材料の化学組成の関連する選択によって、特定の変態温度を予め設定することができる。
変態温度を、１０℃～患者の体温の範囲内に、好ましくは１０℃～室温の範囲内に設定することが特に好ましい。そうすることは、特に患者の体内でインプラントとして使用されている医療デバイスに関して有利であり得る。したがって、この点に関して前記ステントの移植時に確実にする必要があるのは、前記ステントを移植部位で室温又は患者の体温（３７℃）まで温めて、ステント材料の形状記憶効果を発現させることだけである。
上述のような本開示は、心臓弁狭窄及び／又は心臓弁閉鎖不全の治療に使用される、拡張型又は自己拡張ステント及び弁を備える心臓弁プロテーゼ（体内プロテーゼ）に関する。さらに、本開示は、心臓弁狭窄及び／又は心臓弁閉鎖不全の治療用の、カテーテルを用いて移植部位に送達されることができるステントを組み込んだ折畳み可能かつ拡張可能なプロテーゼに関する。前記ステント及びこれに取り付けられた前記弁プロテーゼは、４つの異なる心臓弁のいずれか、特に肺動脈弁及び大動脈弁を置換するために使用されることができるが、罹患した大動脈弁の治療のための本開示の適用を単に単純化のために上記で説明した。
上記の開示は、例示的であることを意図し、網羅的なものではない。本明細書は、多くの変形形態及び代替案を当業者に提案し得る。全てのこれらの代替案及び変形形態は、特許請求の範囲の範囲内に含まれることを意図するものであり、そこで「備える」という用語は「を含むが、それらには限定されない」を意味する。当分野に精通している者は、本明細書で説明する特定の実施形態の他の等価物を認識してもよく、これらの等価物も特許請求の範囲に包含されることを意図するものである。
さらに、従属請求項に提示される特定の特徴は、本開示の範囲内で他の方法で互いに組み合わせることができ、それにより、本開示は、具体的には従属請求項の特徴の任意の他の可能な組合せを有する他の実施形態をも対象とするものと認識されるべきである。例えば、請求項の公開の目的のため、複数従属形式が管轄内で受け入れられる形式である場合、後に続く任意の従属請求項は、代わりにこうした従属請求項で言及される全ての先行詞を所有する全ての先の請求項に複数従属する形で書かれているものと見なされるべきである（例えば、請求項１に直接従属する各請求項は、代わりに全ての先の請求項に従属するものと見なされるべきである）。複数従属請求項形式が制限されている管轄では、後に続く従属請求項はまた、それぞれが代わりに、こうした下位の従属請求項に記載された特定の請求項以外の先の先行詞所有請求項への従属をもたらす各単一従属請求項形式で書かれているものと見なされるべきである。
１１ 弁輪径（ＡＤ）
１２ 弁輪と交連との間の距離（ＡＣＤ）
２１ 自己交連
２２ 自己弁尖
２３ 自己弁輪
２４ ＴＨＶ交連
２５ ＴＨＶ流入端セクション
２６ ＴＨＶ
３１ 交連位置合わせ手段
３２ ＴＨＶ交連
３３ 交連位置合わせ手段
３４ ＴＨＶ
４１ 交連位置合わせ手段
４２ ＴＨＶ交連
４３ 交連位置合わせ手段
４４ ＴＨＶ
５０ 弁
５１ 位置合わせ手段
５２ 血流
５３ ＳＴＪ
５４ 洞
５５ 弁輪

Claims (6)

  1. セル、流入端領域及び流出端領域を備えるステントと弁構成要素とを備える置換心臓弁プロテーゼであって、
    １．０１～１．１４の、弁輪と交連との間の距離の弁輪径に対する弁比を有し、
    ｃｍ２面積当たりのセル数が、前記流入端領域では２～６、前記流出端領域では１～４であり、
    前記流入端領域では、任意の所与のセルの隣接するセルに対する面積比が０．２５～４であり、
    前記流入端領域では、任意の所与のセルの隣接するセルに対する高さ比が０．５～２であり、
    前記流入端領域では、全てのセルのアスペクト比が１～２であり、
    前記流出端領域では、セルのアスペクト比が１～３であり、
    前記流出端領域では、単一の円周方向列内でセルの面積が異なり、円周方向列内の隣接するセルの面積が５～２５０ｍｍ２ であり、
    前記流出端領域では、単一の円周方向列内でセルの高さが異なり、円周方向列内の隣接するセルの高さが３ｍｍ～３０ｍｍであり、
    前記ステントが、半径方向力の１５～２５％が弁輪領域によって与えられ、前記半径方向力の７５～８５％が弁輪上領域によって与えられる半径方向力分布を有し、
    交連位置合わせ手段の近位端と流入端セクションの遠位端との間の距離が、４～１２ｍｍであることを特徴とする、置換心臓弁プロテーゼ。
  2. 前記ステントが少なくとも１つの位置合わせ手段をさらに備える、請求項１に記載のプロテーゼ。
  3. 前記位置合わせ手段が、１若しくは複数の自己弁尖内に導入されるフィーラであるか、又は／及び１若しくは複数の自己弁交連と係合する交連位置合わせ手段であり、前記プロテーゼの近位端の一部であるか又はこれに固着されている、請求項２に記載のプロテーゼ。
  4. 前記ステントが弁組織の固着用の締結部をさらに備える、請求項１に記載のプロテーゼ。
  5. 前記締結部がアーチである、請求項４に記載のプロテーゼ。
  6. 心臓弁狭窄又は心臓弁閉鎖不全の治療に使用するための、請求項１～請求項５のいずれか一項に記載のプロテーゼ。
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