JP6721770B2 - 人工僧帽弁用の構造部材 - Google Patents
人工僧帽弁用の構造部材 Download PDFInfo
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- JP6721770B2 JP6721770B2 JP2019151322A JP2019151322A JP6721770B2 JP 6721770 B2 JP6721770 B2 JP 6721770B2 JP 2019151322 A JP2019151322 A JP 2019151322A JP 2019151322 A JP2019151322 A JP 2019151322A JP 6721770 B2 JP6721770 B2 JP 6721770B2
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- valve
- frame
- tether
- inner frame
- outer frame
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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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
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- A—HUMAN NECESSITIES
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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- A—HUMAN NECESSITIES
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/0005—Use of materials characterised by their function or physical properties
- A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
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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
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
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- A—HUMAN NECESSITIES
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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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
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- A—HUMAN NECESSITIES
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- 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
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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- A—HUMAN NECESSITIES
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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
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- 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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- 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
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Dermatology (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Urology & Nephrology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Botany (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Materials Engineering (AREA)
- Hematology (AREA)
- Prostheses (AREA)
Description
カバーとしての役割を果たす)内側ワイヤフレームの周りに配置された外側円筒状ラップ152と、(弁機能を決定する連接式小葉138から構成された)小葉構造136と、を含む。小葉構造136は内側ワイヤフレーム100に縫合可能である。ワイヤフレーム100はまた、(繋ぎ材)取付開口部111を有し、取付開口部111には繋ぎ材160を取り付けることができる。繋ぎ材160は繋ぎ材定着部154に接続され、繋ぎ材定着部154はこの実施形態では心外膜固定パッドとして実装される。
あり得る。この例では、ワイヤの連接式半径方向突出部又は支柱は、弁が展開される場所に依存して、交互に大小のワイヤの連接式半径方向突出部又は支柱のパターンを形成し得ることが考えられる。人工僧帽弁の場合、使用前の撮像により、特定の患者の僧帽弁近傍の解剖学的な形状に依存してカフの構造をカスタマイズすることが可能になり得る。
幾何学的形状として構成されてもよく、そのそれぞれは圧潰又は圧縮し、その後拡張してその機能的な形状に戻ることができる。いくつかの実施形態では、2つ、3つ又は4つのアーチが存在し得る。別の実施形態では、閉鎖された円形又は楕円形構造設計が考えられる。別の実施形態では、ワイヤ構造物は傘状の構造、又は、他の類似の展開及びロック解除型(unfold-and-lock-open)の設計であってもよい。いくつかの実施形態では、超弾性ニチノール(登録商標)ワイヤは約0.015インチ直径を利用する。この実施形態では、ワイヤは、2〜3本の交連ポストが形成されるような方法で成形用固定具の周りに巻かれる。巻かれたワイヤを含む固定具は、ワイヤ構造物の形態を設定しその超弾性特性を付与するために、所定の温度でマッフル炉に配置される。続いて、ワイヤ構造物の結ばれていない端部はステンレス鋼又はニチノール(登録商標)チューブに結合され、連続的な形状を形成するように捲縮される。いくつかの実施形態では、ワイヤ構造物の交連ポストは、それらの先端で、円形接続リング、すなわち暈(halo)によって隣接され、その目的はポストの内向きの偏向を最少化することである。
録商標)、Peri-Guard(登録商標)、及びVascu-Guard(登録商標)で使用されるものを
含み、全ての製品は外科手術で現在使用され、30か月齢未満のウシから一般的に採取されて市販されている。
ラフルオロエチレンなどの合成材料から作製されてもよい。薄い、耐久性のある合成材料が、例えば拡張端部又はカフをカバーするために考慮される場合、発泡ポリテトラフルオロエチレン又はポリエステルなどの合成ポリマー材料が任意選択的に使用されてもよい。他の適切な材料は、熱可塑性ポリカーボネートウレタン、ポリエーテルウレタン、セグメント化されたポリエーテルウレタン、シリコーンポリエーテルウレタン、シリコーン−ポリカーボネートウレタン、及び、超高分子量ポリエチレンを任意選択的に含んでもよい。さらなる生体適合性ポリマーは、ポリオレフィン、エラストマー、ポリエチレン−グリコール、ポリエーテルスルフォン、ポリスルフォン、ポリビニルピロリドン、ポリビニルクロリド、他のフルオロポリマー、シリコーンポリエステル、シロキサンポリマー及び/又はオリゴマー、及び/又は、ポリラクトン、及び、それらを使用するブロックコポリマーを任意選択的に含んでもよい。
exPFTF(ポリテトラフルオロエチレン)又は2−0 ポリプロピレンを含む。一実施形態において、繋ぎ材は非弾性的である。繋ぎ材の1以上は、心臓周期の間、さらにより高い程度の弁の順応性を提供するために任意選択的に弾性であってもよい。心臓の頂部まで及び心臓の頂部を通して引っ張られると、繋ぎ材は、繋ぎ材が心室へ後退しないように、結紮などの適切な機構によって、綿球又は類似の調整可能なボタン型定着装置に結合することができる。繋ぎ材が生体再吸収性/生体吸収性であり、従って、他の種類の固定が、組織と人工弁の間のそのような生物学的線維性癒着及び/又は心臓の室の拡大の程度の低減による半径方向の圧縮をもたらすまで、一時的な固定を提供し得ることも考えられる。
心室の中に延びる(環状部と心室頂部の間の距離の約25%)。開かれた本来の小葉は、外側フレーム壁にもたれかかり、及びフレームの長軸と平行に横たわる(すなわちフレームは本来の僧帽弁小葉を開いた状態に維持する)。
形態で規定される。図4はまた横架部材122を示し、横架部材122は、ダイヤモンド状部材の開放スパン部分を横断し、補強構造強化、別の縫合用定着位置又はその両方を提供する。図4は点A及び点Bを示し、それらは円筒状構造を形成するために接続部材が結合される位置である(又は別の言い方をすれば、管状内側フレーム100が図4に示される見た目のように開かれて平らにされるように切断される位置である)。
図14Aの初期構成よりもわずかに小さい半径方向寸法まで圧縮され、及び、カフ部分246及び本体部分245はわずかにより広い半径方向寸法まで拡張されている。図14Cは、(最終的な展開構造まで完全に変形されていないが)さらに部分的に変形された外側フレーム244を示す。
接続部分344との間で、長手方向の接続と半径方向の移行を形成する。
提供するべく2つのフレームに対するカバーを支持し、及び、心室壁に対する繋ぎ材接続によって人工弁を本来の弁環状部内で適所に保持することに役立つために(内側フレーム340によって)繋ぎ材と結合する。2つのフレームは6つの結合点で接続される(代表的な点は「C」として認定される)。この実施形態において、結合点は、短い長さのワイヤなどの機械的結合具によって実現され、外側フレーム370の結合部分371の開口(開口371Aなど)及び内側フレーム340の本体部分342の長手方向支柱(支柱342Aなど)の対応する開口を通される。従って内側フレーム構造340は外側フレーム370内に配置され、それに対して固定され結合される。
Claims (9)
- 拡張された形状記憶合金から形成された外側フレームと、
前記外側フレームに結合された内側フレームであって、初期形状から拡張された本体部分と、初期形状から圧縮された接続部分と、を有する形状記憶合金から形成された内側フレームと、を備え、
前記内側フレームは、人工弁小葉アセンブリを前記本体部分内に支持するように構成され、
前記接続部分は、対向するV字形の接続部材の複数対によって円周方向に接続されたストラットの長手方向延伸を規定し、前記接続部分内に内腔が規定され、前記内腔は、前記内腔内で繋ぎ材に係合するように構成され、前記接続部分に適用された圧縮力に応答して、(1)前記V字形の接続部材の頂点は長手方向に相互に近くに移動するように構成され、(2)前記V字形の接続部材の開放端部は円周方向に相互に近くに移動するように構成される、装置。 - 前記内側フレームは機械的結合具によって前記外側フレームに接続される、請求項1に記載の装置。
- 前記繋ぎ材をさらに備え、前記繋ぎ材の端部部分は、前記内側フレームが心臓内に配置された時に心臓の心外膜表面まで前記繋ぎ材の反対の端部が延在して前記内側フレームを前記心外膜表面に固定するように、前記内側フレームの前記接続部分の前記内腔内から延在する、請求項1に記載の装置。
- 前記外側フレームに形成されたX線不透過性インジケータをさらに備える、請求項1に記載の装置。
- 前記内腔は、幅と、前記幅より大きい長さと、を有する、請求項1に記載の装置。
- 前記内側フレームの前記本体部分内に支持された前記人工弁小葉アセンブリをさらに備える、請求項1に記載の装置。
- 前記外側フレームは前記内側フレームとは別個に形成されて前記内側フレームに結合される、請求項1に記載の装置。
- 前記外側フレームの直径を越えて突出するカフをさらに備える、請求項1に記載の装置。
- 前記接続部分は、前記繋ぎ材の端部が前記内腔内に係合させられた時に前記繋ぎ材の前記端部を圧縮によりクランプするように構成される、請求項1に記載の装置。
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JP2020146570A (ja) | 2020-09-17 |
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