JP4712031B2 - 制御下で分離する、心臓弁フレーム - Google Patents
制御下で分離する、心臓弁フレーム 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
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2220/0066—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements stapled
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Description
本発明は、プロテーゼ用の心臓弁のための内部支持フレームに関し、より具体的には、移植後に、心臓弁膜尖へと分離する、小葉を有する支持フレームに関する。
プロテーゼ用の心臓弁は、損傷を受けたか、もしくは病的な心臓弁を置換するために使用される。脊椎動物において、心臓は、4つの駆動チャンバ:左心房および右心房、ならびに左心室および右心室を有する中空の筋肉器官であり、この各々は、各自の一方向拍出弁を備える。天然の心臓弁は、大動脈弁、僧帽弁(または二尖弁)、三尖弁および肺動脈弁として識別される。心臓の弁は、その内部の室を隔て、そして、各々が、室の間の輪に付着している。この輪は、動脈および静脈の筋線維に、直接的もしくは間接的に取り付けられた、高密度な線維性の環を備える。弁置換手術において、損傷を受けた小葉は、代表的に、切除されて、そして、代替の弁を受容するために、輪が彫られる(sculpt)。
本発明は、移植の間にその形状を維持するが、その後、最終的に複数の心臓弁膜尖へと分離する、プロテーゼ用の心臓弁のための改善された小葉支持フレームを提供する。この支持フレームは、交互性の心臓弁膜尖、およびその心臓弁膜尖の縁部に沿ってフレームに固定された複数の可撓性の小葉(1フレームあたり1つの心臓弁膜尖)を備える交連を備える。フレームの交連は、心臓弁膜尖が、互いに関して実質的に独立して動くように、移植後の所定の時点で壊れるように設計される。先行技術における生分解性の心臓弁膜尖の結合とは対照的に、このフレームの交連は、フレームの心臓弁膜尖と実質的に同じ材料の曲げにおける剛性を有し、その結果、弁の心臓弁膜尖が、移植の間の弁の不可避な操作から、時期を早めて互いに自由になる可能性を実質的に制限する。
本発明は、主に、大動脈位への移植に適した、非常に可撓性のプロテーゼ用心臓弁を提供する。特に、このプロテーゼ用心臓弁は、内部支持フレームの波状の形状に沿った、取付け具またはソーイングバンドを有する。従って、このソーイングバンドは、天然の大動脈輪および上行性大動脈の線維性の心臓弁膜尖および交連の上下に(例えば、縫合により)取り付けられ得る。しかし、本発明の心臓弁の特徴はまた、他の弁位置(例えば、三尖弁位)における使用にも適切であり得ることが理解されるはずである。
Claims (19)
- 可撓性の小葉を持つプロテーゼ用心臓弁のための支持フレームであって、以下:
複数の心臓弁膜尖であって、該心臓弁膜尖の各々が、該心臓弁の可撓性の小葉の心臓弁膜尖を支持するような大きさおよび形状である、心臓弁膜尖;ならびに
複数の交連であって、各個々の交連が、心臓弁膜尖の各隣接する対の間にあり、該交連の各々は、移植後に、該心臓弁膜尖が、互いに関して実質的に独立して移動するように、該心臓弁膜尖の相対的な反復運動の際に、壊れるように設計された脆弱点を有する、交連を備え、該支持フレームは、連続した均質な材料から形成される単一の連続した要素であり、該交連および心臓弁膜尖が、曲げにおいて、該疲労の点に到達する前の、実質的に同じ材料の剛性を有する、支持フレーム。 - 前記支持フレームが、Nitinolから作製される、請求項1に記載の支持フレーム。
- 前記支持フレームの心臓弁膜尖の各々が、2つの交連領域で平行運動し、そして、該交連において、前記脆弱点が、隣接する交連領域の間に壊れやすいブリッジを備える、請求項1に記載の支持フレーム。
- 前記壊れやすいブリッジが、隣接する部分と比べて、前記支持フレームの狭い部分を備える、請求項3に記載の支持フレーム。
- 前記脆弱点が、ノッチを備える、請求項3に記載の支持フレーム。
- 前記交連領域が、前記壊れやすいブリッジのいずれかの側の、拡張された耳の内部で終結し、拡張された耳の各々が前記隣接する交連領域の断面より大きな断面を有する、請求項3に記載の支持フレーム。
- 請求項6に記載の支持フレームであって、該支持フレームは、該支持フレームを覆う生体適合性の織物をさらに備え、前記拡張された耳は、いったん前記壊れやすいブリッジが壊れると、該織物から、前記交連領域が突き出ることを防止するような大きさである、支持フレーム。
- 可撓性の小葉をもつ、プロテーゼ用心臓弁のための支持フレームであって、以下:
該心臓弁の可撓性の小葉の心臓弁膜尖を支持するような大きさおよび形状の、複数の心臓弁膜尖;ならびに
複数の交連であって、各個々の交連が、心臓弁膜尖の各隣接する対の間にあり、該交連および心臓弁膜尖は、一体になった均質の材料から形成され、そして、
該交連の各々は、移植後に、該心臓弁膜尖が、互いに関して実質的に独立して移動し得るように、該心臓弁膜尖の相対的な反復運動の際に、壊れるように設計された脆弱点を有する、交連を備え、該交連および心臓弁膜尖が、曲げにおいて、該疲労の点に到達する前の、実質的に同じ材料の剛性を有する、支持フレーム。 - 前記支持フレームが、3つの心臓弁膜尖および3つの交連を備える、請求項8に記載の支持フレーム。
- 前記支持フレームが、Nitinolから作製される、請求項8に記載の支持フレーム。
- 請求項8に記載の支持フレームであって、各心臓弁膜尖が2つの交連領域へと移行し、該交連において、前記脆弱点は、隣接する交連領域の間に壊れやすいブリッジを備える、支持フレーム。
- 前記壊れやすいブリッジが、隣接する部分と比べて、前記支持フレームの狭い部分を備える、請求項11に記載の支持フレーム。
- 前記脆弱点が、ノッチを備える、請求項11に記載の支持フレーム。
- 前記交連領域が、前記壊れやすいブリッジのいずれかの側の、拡張された耳の内部で終結し、拡張された耳の各々が前記隣接する交連領域の断面より大きな断面を有する、請求項11に記載の支持フレーム。
- 請求項14に記載の支持フレームであって、該支持フレームは、該支持フレームを覆う生体適合性の織物をさらに備え、前記拡張された耳は、いったん前記壊れやすいブリッジが壊れると、該織物から、前記交連領域が突き出ることを防止するような大きさである、支持フレーム。
- 天然の心臓弁を置換するための、可撓性の小葉を持つプロテーゼ用心臓弁であって、該可撓性の小葉を持つプロテーゼ用心臓弁は、交互性の心臓弁膜尖および交連を備える内部支持フレームを有する可撓性の小葉を持ち、該可撓性の小葉の心臓弁膜尖は、該支持フレームの心臓弁膜尖に沿って取り付けられており、該内部支持フレームの交連は、移植後に、該支持フレームの心臓弁膜尖が、互いに関して実質的に独立して移動するように、該心臓弁膜尖の相対的な反復運動の際に、壊れるように設計され、該内部支持フレームが、移植工程の間に、該内部支持フレームに付与される実質的な圧縮力に耐え、そして、該圧縮力から跳ね返る連続した可撓性要素から作製され、該交連および心臓弁膜尖が、曲げにおいて、該疲労の点に到達する前の、実質的に同じ材料の剛性を有する、可撓性の小葉を持つプロテーゼ用心臓弁。
- 前記可撓性の小葉を持つプロテーゼ用心臓弁が、圧縮され、そして、侵襲性の少ない手順で、管を通して移植部位へと送達されるように構成されている、請求項16に記載の可撓性の小葉を持つプロテーゼ用心臓弁。
- 請求項16に記載の可撓性の小葉を持つプロテーゼ用心臓弁であって、前記可撓性の小葉を持つプロテーゼ用心臓弁が、大動脈の位置に移植されるように設計され、そして、さらに、前記支持フレームの交互性の心臓弁膜尖および交連がつながったソーイングバンドを備え、ここで、該ソーイングバンドは、前記天然の大動脈輪の線維性の心臓弁膜尖および交連の上下に取り付けられるように構成されており、そして該可撓性の小葉を持つプロテーゼ用心臓弁は、大動脈を遡るように構成されている、可撓性の小葉を持つプロテーゼ用心臓弁。
- 前記内部支持フレームの交連が、移植後約2日と2週間との間に壊れるように設計される、請求項16に記載の可撓性の小葉を持つプロテーゼ用心臓弁。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/811,565 US20050228494A1 (en) | 2004-03-29 | 2004-03-29 | Controlled separation heart valve frame |
US10/811,565 | 2004-03-29 | ||
PCT/US2005/009863 WO2005097003A1 (en) | 2004-03-29 | 2005-03-24 | Controlled separation heart valve frame |
Publications (3)
Publication Number | Publication Date |
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JP2007530230A JP2007530230A (ja) | 2007-11-01 |
JP2007530230A5 JP2007530230A5 (ja) | 2008-05-08 |
JP4712031B2 true JP4712031B2 (ja) | 2011-06-29 |
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JP2007506272A Expired - Fee Related JP4712031B2 (ja) | 2004-03-29 | 2005-03-24 | 制御下で分離する、心臓弁フレーム |
Country Status (7)
Country | Link |
---|---|
US (1) | US20050228494A1 (ja) |
EP (1) | EP1729688B1 (ja) |
JP (1) | JP4712031B2 (ja) |
AU (1) | AU2005231305A1 (ja) |
BR (1) | BRPI0509280A (ja) |
CA (1) | CA2559524C (ja) |
WO (1) | WO2005097003A1 (ja) |
Families Citing this family (61)
Publication number | Priority date | Publication date | Assignee | Title |
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US6530952B2 (en) * | 1997-12-29 | 2003-03-11 | The Cleveland Clinic Foundation | Bioprosthetic cardiovascular valve system |
US6602286B1 (en) | 2000-10-26 | 2003-08-05 | Ernst Peter Strecker | Implantable valve system |
US8308797B2 (en) | 2002-01-04 | 2012-11-13 | Colibri Heart Valve, LLC | Percutaneously implantable replacement heart valve device and method of making same |
US6752828B2 (en) | 2002-04-03 | 2004-06-22 | Scimed Life Systems, Inc. | Artificial valve |
US6945957B2 (en) | 2002-12-30 | 2005-09-20 | Scimed Life Systems, Inc. | Valve treatment catheter and methods |
US8128681B2 (en) | 2003-12-19 | 2012-03-06 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
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- 2005-03-24 EP EP05729875.4A patent/EP1729688B1/en active Active
- 2005-03-24 CA CA2559524A patent/CA2559524C/en active Active
- 2005-03-24 JP JP2007506272A patent/JP4712031B2/ja not_active Expired - Fee Related
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BRPI0509280A (pt) | 2007-09-18 |
US20050228494A1 (en) | 2005-10-13 |
EP1729688A1 (en) | 2006-12-13 |
JP2007530230A (ja) | 2007-11-01 |
CA2559524C (en) | 2013-05-07 |
CA2559524A1 (en) | 2005-10-20 |
AU2005231305A1 (en) | 2005-10-20 |
WO2005097003A1 (en) | 2005-10-20 |
EP1729688B1 (en) | 2015-08-12 |
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