JP2011515115A - 二尖の血管弁ならびにその製作および移植の方法 - Google Patents
二尖の血管弁ならびにその製作および移植の方法 Download PDFInfo
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- 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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- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
- A61F2/2475—Venous valves
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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
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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
- A61F2/2412—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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Abstract
Description
本出願は、2005年1月24日に出願された米国特許出願番号第11/041,603号の一部継続出願であり、2004年1月23日に出願された米国の仮特許出願番号第60/538,870号の利益を主張するものである。両方の出願の全体の内容は参照により本明細書に組み入れられる。
1)心臓の2つの下部心室の間に穴のある心室中隔欠損(VSD);
2)肺動脈狭窄、または肺動脈弁、もしくは肺動脈弁よりもわずかに下流における狭小;
3)心室中隔上への大動脈騎乗;および
4)右心室の異常な筋肥大。
1)クラスIIまたはそれ以上の労作性の症状
2)RV(右心室)の収縮機能障害および/または拡張
3)運動耐容能の低下
4)心室性の不整脈および/または160ミリセカンド以上のQRSの持続時間
16 切開(楕円形の形状の平らなシート)
22 楕円形の形状(平らなシート)
26 第1の端部(血管弁)
28 可撓性の部材(血管弁)
30 第2の端部(血管弁)
34 オリフィス(血管弁)
42 チューブ状の要素(血管弁)
46 長軸(楕円形の形状の平らなシート)
48 短軸(楕円形の形状の平らなシート)
50 右心室流出路(ヒト心臓)
52 第1の縁部(短軸)
54 第2の縁部(短軸)
56a 自由な縁部(オリフィス)
56b 自由な縁部(オリフィス)
58 切開(右心室流出路/他の血管)
60 直径(血管)
62 周辺縁部(短軸)(楕円形の形状/血管弁)
66 縫合
70 漏斗部中隔(右心室流出路)
100 ステント
102 ワイヤー(ステント)
104 生体適合性材料(ステント被覆用)
106 縫合(ステント/移植(グラフト)チューブ)
108 ステントストラット(ステント)
110 縫合(ステント)
112 移植(グラフト)チューブ
114 出口端部(入口端部)(縁部分)(ステント/移植(グラフト)チューブ)
116 内側部分(移植(グラフト)チューブ)
Claims (14)
- 第1の端部および第2の端部を有する略チューブ状の要素を備え;
前記第1の端部は、第1の位置または第2の位置のいずれかの位置をとることができるオリフェスを有し、前記オリフェスは前記第1の位置において平坦かつ略閉塞するとともに、前記第2の位置において略円形かつ開くように構成され;
前記第2の端部は、少なくとも2つの可撓性の部材を有し、前記可撓性の部材の各々はフレーム構造体を持たない縁部領域により構成され;
前記オリフィスが略閉塞している場合において、前記少なくとも2つの向かい合う自由な縁部の間の前記オリフィスの長さは、患者の右心室流出路または血管の直径の約1.5倍乃至2倍に等しいものとなるように構成された;
血管弁。 - 前記弁は、縫合および前記可撓性の部材に取り付けられたプロングの右心室流出路すなわち血管壁への移植の少なくともいずれか一方により患者の血管壁に取り付け可能に設けられた、請求項1に記載の血管弁。
- 前記チューブ状の要素は、フッ素重合体、ポリテトラフルオロエチレン、および生体適合性の合成樹脂のいずれか1つから形成される、請求項1に記載の血管弁。
- 外側のチューブ状の構造をさらに備え、前記チューブ状の要素が前記外側のチューブ状の構造の内部に配置されるように、前記可撓性の部材は前記外側のチューブ状の構造に対して取り付けられる、請求項1に記載の血管弁。
- 前記外側のチューブ状の構造は、ステント、移植チューブ、またはステントおよび移植チューブの両方のいずれか1つにより構成された、請求項4に記載の血管弁。
- 弁が移植される予定の患者の血管の直径に部分的に基づいて血管弁を製作する方法であって、
短軸を有する略楕円形の形状を1枚の可撓性を有する合成された生体適合性の材料から切り出すステップと;
前記患者の血管の直径の約1.5倍乃至2倍に等しい距離で前記短軸に沿って切開が延在するように、前記楕円形の形状を前記短軸の一部分に沿って前記切開するステップと;
前記短軸に沿って前記楕円形の形状を折り畳んで前記楕円形の形状の端部から2つの可撓性の部材を設けるステップと;
前記患者の右心室流出路または血管に挿入された場合に略チューブ状の形状を形成し、その一方の端部において有する前記切開が開閉可能なオリフィスを形成するように、前記折り畳まれた楕円形の形状を設けるステップとを備える;
方法。 - 前記楕円形の形状の切開は前記楕円形の形状の縁部からそれぞれ約1mm乃至3mmの距離において端部を有する切開を生成するステップを有する、請求項6に記載の方法。
- 前記楕円形の形状の切開は前記楕円形の形状の前記縁部からそれぞれ約2mmにおいて端部を有する切開を生成するステップを有する、請求項7に記載の方法。
- 移植可能な弁を製作する方法であって:
短軸を有する略楕円形の形状を1枚の可撓性を有する合成された生体適合性の材料から切り出すステップと;
患者の血管の直径の約1.5倍乃至2倍に等しい距離で前記短軸に沿って切開が延在するように、前記楕円形の形状を前記短軸の一部分に沿って前記切開するステップと;
前記楕円形の形状を前記短軸に沿って折り畳んで少なくとも2つの可撓性の部材を設けるステップと;
前記可撓性を有する合成された生体適合性の材料が、略チューブ状の形状を形成し、その一方の端部において有する前記切開が開閉可能なオリフィスを形成するように、前記切開を所定の直径および形状のオリフィスへと設けるステップとを備える;
方法。 - 前記可撓性の部材が互いに略平行であり、前記略チューブ状の構造が維持されて、前記可撓性の部材が前記患者の血管の前壁および後壁に対して縫合されるように構成された、請求項9に記載の方法。
- 前記患者の右心室流出路の漏斗部中隔の前壁および後壁に対して縫合されるように、前記可撓性の部材が構成される、請求項9に記載の方法。
- 前記可撓性の部材が互いに略平行であり、前記略チューブ状の構造が維持されて弁を形成するように、前記患者の血管への挿入のためにサイズを調整されたステントまたは移植チューブに対して各々の前記可撓性の部材を取り付けるステップをさらに備える、請求項9に記載の方法。
- 前記可撓性の部材が互いに略平行であり、前記略チューブ状の構造が維持されて弁を形成するように、前記患者の心臓への挿入のためにサイズを調整されたステントまたは移植チューブに対して各々の前記可撓性の部材を取り付けるステップをさらに備える、請求項9に記載の方法。
- 患者の右心室流出路の再構築をおこなう方法であって:
長軸および短軸を有し、短軸が所定の長さを有して少なくとも2つの周辺縁部を有する略楕円形の形状を、可撓性を有する合成された生体適合性の材料からなる平らなシートから切り出すステップと;
前記患者の右心室流出路の約1.5倍乃至2倍の直径に等しい距離で前記短軸に沿って切開が延在し、前記少なくとも2つの周辺縁部を有するように、前記楕円形の形状を前記短軸に沿って前記切開するステップと;
前記楕円形の形状を前記短軸に沿ってそれ自体の上で2分の1に折り畳むステップと;
前記可撓性の合成された生体適合性の材料が患者の血管へと挿入された場合に、略チューブ状の形状を形成し、その一方の端部において有する前記切開が開閉可能なオリフィスを形成するように、前記切開を所定の直径および形状のオリフィスへと設けるステップとを備え;
前壁および後壁に対して縫合された場合に、前記可撓性の部材が互いに略平行であり、前記前壁および後壁に対して縫合された場合に、前記略チューブ状の構造が維持されることによって前記弁の前記オリフィスが右心室流出路を通過する血液の流れにより開閉可能であるように、前記複数の可撓性の部材を右心室流出路の漏斗部中隔の前壁および後壁に対して縫合するように構成された;
方法。
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Application Number | Priority Date | Filing Date | Title |
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US11/939,452 US7862610B2 (en) | 2004-01-23 | 2007-11-13 | Bicuspid vascular valve and methods for making and implanting same |
US11/939,452 | 2007-11-13 | ||
PCT/US2008/083426 WO2009064903A1 (en) | 2007-11-13 | 2008-11-13 | Bicuspid vascular valve and methods for making and implanting same |
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JP2011515115A true JP2011515115A (ja) | 2011-05-19 |
JP2011515115A5 JP2011515115A5 (ja) | 2011-12-22 |
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AU (1) | AU2008320957B2 (ja) |
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US11672651B2 (en) | 2011-07-29 | 2023-06-13 | Carnegie Mellon University | Artificial valved conduits for cardiac reconstructive procedures and methods for their production |
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EP2842517A1 (en) * | 2011-12-29 | 2015-03-04 | Sorin Group Italia S.r.l. | A kit for implanting prosthetic vascular conduits |
US9283072B2 (en) | 2012-07-25 | 2016-03-15 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
US10376360B2 (en) * | 2012-07-27 | 2019-08-13 | W. L. Gore & Associates, Inc. | Multi-frame prosthetic valve apparatus and methods |
US10966820B2 (en) | 2012-12-19 | 2021-04-06 | W. L. Gore & Associates, Inc. | Geometric control of bending character in prosthetic heart valve leaflets |
US9737398B2 (en) | 2012-12-19 | 2017-08-22 | W. L. Gore & Associates, Inc. | Prosthetic valves, frames and leaflets and methods thereof |
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Also Published As
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AU2008320957A1 (en) | 2009-05-22 |
EP2217175A1 (en) | 2010-08-18 |
US7862610B2 (en) | 2011-01-04 |
WO2009064903A1 (en) | 2009-05-22 |
US20080065198A1 (en) | 2008-03-13 |
CA2705591A1 (en) | 2009-05-22 |
KR20100094990A (ko) | 2010-08-27 |
AU2008320957B2 (en) | 2014-03-13 |
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