JP4287272B2 - 医療装置のための高分子弁膜構造 - Google Patents
医療装置のための高分子弁膜構造 Download PDFInfo
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- JP4287272B2 JP4287272B2 JP2003528266A JP2003528266A JP4287272B2 JP 4287272 B2 JP4287272 B2 JP 4287272B2 JP 2003528266 A JP2003528266 A JP 2003528266A JP 2003528266 A JP2003528266 A JP 2003528266A JP 4287272 B2 JP4287272 B2 JP 4287272B2
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- Prior art keywords
- valve
- support structure
- membrane
- prosthesis
- valve membrane
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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.)
- Expired - Lifetime
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Classifications
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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
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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
- 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
- A61F2250/0029—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 bending or flexure capacity
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
Description
改良された高分子弁膜は、弁付きプロテーゼにおいて使用することができる。特に、人工心臓、心臓弁プロテーゼ、弁付き血管プロテーゼ、または、左心補助循環装置に弁膜を使用することができる。弁を通じた流れを制御するために、高分子弁膜が開閉する。
一般に、当該弁の全てを生体適合性材料によって形成しなければならない。患者内に埋め込まれない弁の場合であっても、これらの弁が患者の血液または他の体液と接触する場合には、材料を生体適合性にすることが望ましい。好ましい材料は、一般に、弁部品の所望の機械的特性によって決まる。具体的には、支持構造体のための好ましい材料の性質は、支持構造体を硬質にしようとするか否かによって決まる。弁膜の材料および構造は、所望レベルの寿命、引き裂き抵抗、機械的性能を達成するように選択される。
支持構造体とは別個に弁膜を形成することができ、あるいは、支持構造体と直接に関連付けて弁膜を形成することができる。弁膜を支持構造体とは別個に形成する場合には、構成要素の特定の材料に適する手法によって、弁膜を支持構造体に対して取り付けることができる。例えば、ヒートシール(熱接着)、縫合、接着等によって高分子弁膜を適当な支持構造体に対して接続することができる。支持構造体が同じ材料によって形成されるかどうかにかかわらず、支持構造体と直接に関連付けて弁膜を形成することができる。支持構造体と直接に関連付けて弁膜を形成する場合、後述するように、弁膜形成プロセスに支持構造体を組み込むことができる。
配送において、医療装置は、シールされて殺菌された容器内に収納される。医療装置の構成要素を永久に保管すべきでない場合、容器には、日付が望ましい最大保管期間を示すように、年月日が付されても良い。容器は、医療装置の適切な使用及び/又は移植のための指示書と、他の適当な及び/又は必要なラベリングと共に包装される。容器は、プロテーゼ等の移植といった適切な医療処置で使用するため、医療専門家へと配送される。例えば標準的な外科手術を使用して、心臓弁プロテーゼおよび弁付き血管プロテーゼを移植する(埋め込む)ことができる。
Claims (13)
- 支持構造体(308)と、この支持構造体に接続される複数の柔軟な高分子弁膜(302、304)とを備え、前記支持構造体は、複数の交連支持体と、交連支持体間にあるスカラップとを有し、前記柔軟な高分子弁膜は、流入端部に最も近いスカラップに沿う部位で、弁軸と直交する面に対して流入端部の方へ約5°〜約85°の角度(θ)を成して、支持構造体に接続している弁付きプロテーゼ(300)であって、前記支持構造体が前記弁膜と同じ高分子材料で形成またはコーティングされ、前記弁膜が前記支持構造体に直接関連して形成されている、弁付きプロテーゼ。
- 前記柔軟な高分子弁膜は、弁半径の約1倍〜弁半径の約2倍の弁高さを有する弁を形成するとともに、弁高さよりも少なくとも約1ミリメートル長い弁膜長を有している請求項1に記載の弁付きプロテーゼ。
- 前記支持構造体は、硬質なステントを含んでいる請求項1に記載の弁付きプロテーゼ。
- 前記支持構造体は、柔軟な材料を含んでいる請求項1に記載の弁付きプロテーゼ。
- 前記柔軟な高分子弁膜は、補強体を備えている請求項1に記載の弁付きプロテーゼ。
- 前記柔軟な高分子弁膜は、流入端部の方へ約10°〜約60°の角度を成して支持構造体に接続している請求項1に記載の弁付きプロテーゼ。
- 前記柔軟な高分子弁膜は、流入端部の方へ約10°〜約50°の角度を成して支持構造体に接続している請求項1に記載の弁付きプロテーゼ。
- 前記弁は、完全に開いたルーメンの少なくとも10%であるルーメンを持つ弛緩状態を有している請求項1に記載の弁付きプロテーゼ。
- 前記弁は、完全に開いたルーメンの少なくとも90%であるルーメンを持つ弛緩状態を有している請求項8に記載の弁付きプロテーゼ。
- 前記弁は、完全に開いたルーメンの約50%〜約80%であるルーメンを持つ弛緩状態を有している請求項8に記載の弁付きプロテーゼ。
- 前記弁は、完全に開いたルーメンの約10%以下のルーメンを持つ弛緩状態を有している請求項1に記載の弁付きプロテーゼ。
- 前記柔軟な高分子弁膜は、ポリウレタン、シリコーン、ポリジメチルシロキサン、ポリテトラフルオロエチレン、これらの誘導体、これらの混合物から成る群から選択される高分子を含んでいる請求項1に記載の弁付きプロテーゼ。
- 前記弁膜は、弁高さよりも約1.5ミリメートル長い長さ〜弁高さの約1.2倍+2ミリメートルの長さの弁膜長を有している請求項2に記載の弁付きプロテーゼ。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/955,703 US6562069B2 (en) | 2001-09-19 | 2001-09-19 | Polymer leaflet designs for medical devices |
PCT/US2002/029786 WO2003024366A1 (en) | 2001-09-19 | 2002-09-19 | Polymer leaflet designs for medical devices |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2005502429A JP2005502429A (ja) | 2005-01-27 |
JP2005502429A5 JP2005502429A5 (ja) | 2006-01-05 |
JP4287272B2 true JP4287272B2 (ja) | 2009-07-01 |
Family
ID=25497230
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003528266A Expired - Lifetime JP4287272B2 (ja) | 2001-09-19 | 2002-09-19 | 医療装置のための高分子弁膜構造 |
Country Status (9)
Country | Link |
---|---|
US (1) | US6562069B2 (ja) |
EP (1) | EP1427356B1 (ja) |
JP (1) | JP4287272B2 (ja) |
AT (1) | ATE480202T1 (ja) |
BR (1) | BR0211839B1 (ja) |
CA (1) | CA2460013C (ja) |
DE (1) | DE60237623D1 (ja) |
ES (1) | ES2349357T3 (ja) |
WO (1) | WO2003024366A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2013052304A (ja) * | 2004-05-05 | 2013-03-21 | Direct Flow Medical Inc | 現場形成支持構造を備えたステントレス心臓弁 |
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2002
- 2002-09-19 BR BRPI0211839-4A patent/BR0211839B1/pt not_active IP Right Cessation
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- 2002-09-19 WO PCT/US2002/029786 patent/WO2003024366A1/en active Application Filing
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JP2013052304A (ja) * | 2004-05-05 | 2013-03-21 | Direct Flow Medical Inc | 現場形成支持構造を備えたステントレス心臓弁 |
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US20030055496A1 (en) | 2003-03-20 |
BR0211839A (pt) | 2004-09-08 |
ATE480202T1 (de) | 2010-09-15 |
US6562069B2 (en) | 2003-05-13 |
CA2460013A1 (en) | 2003-03-27 |
CA2460013C (en) | 2011-07-12 |
ES2349357T3 (es) | 2010-12-30 |
WO2003024366A1 (en) | 2003-03-27 |
EP1427356B1 (en) | 2010-09-08 |
JP2005502429A (ja) | 2005-01-27 |
DE60237623D1 (de) | 2010-10-21 |
BR0211839B1 (pt) | 2012-05-15 |
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