JP2010526573A - 複合形状の血液適合性物品の製造方法とこれにより得られた物品 - Google Patents
複合形状の血液適合性物品の製造方法とこれにより得られた物品 Download PDFInfo
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- JP2010526573A JP2010526573A JP2010506963A JP2010506963A JP2010526573A JP 2010526573 A JP2010526573 A JP 2010526573A JP 2010506963 A JP2010506963 A JP 2010506963A JP 2010506963 A JP2010506963 A JP 2010506963A JP 2010526573 A JP2010526573 A JP 2010526573A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 13
- 239000008280 blood Substances 0.000 title claims description 37
- 210000004369 blood Anatomy 0.000 title claims description 37
- 238000000034 method Methods 0.000 title claims description 7
- 239000012528 membrane Substances 0.000 claims abstract description 37
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims abstract description 22
- 239000004810 polytetrafluoroethylene Substances 0.000 claims abstract description 22
- 239000000835 fiber Substances 0.000 claims abstract description 9
- 238000000576 coating method Methods 0.000 claims description 19
- 239000011248 coating agent Substances 0.000 claims description 18
- 238000000465 moulding Methods 0.000 claims description 18
- -1 polytetrafluoroethylene Polymers 0.000 claims description 7
- 239000012790 adhesive layer Substances 0.000 claims description 6
- 238000001816 cooling Methods 0.000 claims description 4
- 229920001971 elastomer Polymers 0.000 claims description 4
- 239000000806 elastomer Substances 0.000 claims description 4
- 229910052710 silicon Inorganic materials 0.000 claims description 4
- 239000010703 silicon Substances 0.000 claims description 4
- 239000010410 layer Substances 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 238000003856 thermoforming Methods 0.000 description 3
- 238000007664 blowing Methods 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000004696 Poly ether ether ketone Substances 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000000635 electron micrograph Methods 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920002530 polyetherether ketone Polymers 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
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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
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
-
- 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
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/31504—Composite [nonstructural laminate]
- Y10T428/3154—Of fluorinated addition polymer from unsaturated monomers
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Epidemiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Manufacturing & Machinery (AREA)
- Medicinal Chemistry (AREA)
- Surgery (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
- Artificial Filaments (AREA)
Abstract
本発明によれば、その繊維(3)が選択方位を有さないe−PTFEの膜(1)が熱成形される。
【選択図】 図1
Description
− 上記の物品の形状を有する成形用鋳型を作製し、
− ポリテトラフルオロエチレン膜を加熱し、この膜の2つの面同士間に生じる圧力差により上記の成形用鋳型に当がって上記の物品の形状に合わせ、
− こうして形状に合わせられた上記の膜を上記の成形用鋳型に当がったまま冷却し、
− そして上記の膜を成形用鋳型から取り外す方法において、
− 上記の膜が、上記物質の形状に合わせる前まで熱的に安定しない発泡ポリテトラフルオロエチレンで作製され、この膜の繊維が選択方位を有さず、
− 上記の膜を、上記の物質の形状に合わせたまま、上記の発泡ポリテトラフルオロエチレンのゲル化点以上の温度まで加熱することを特徴とする。
図1は、本発明の方法で用いられるe−PTFEで作製された膜(1)の表面の一部の電子顕微鏡図を略示する。こらから分かるように、膜(1)の構造は、複数個の不規則に配分された結節(2)が繊維(3)により連結されてなる。本発明により用いられた膜(1)では、結節(2)も繊維(3)も選択方位を有する配置を形成しない。
Claims (9)
- 血液適合性物品(6)の製造方法であって、
− 上記の物品(6)の形状を有する成形用鋳型(7)を作製し、
− ポリテトラフルオロエチレン膜(1)を加熱し、この膜(1)の2つの面同士間に生じる圧力差により上記の成形用鋳型(7)に当がって上記の物品(6)の形状に合わせ、
− こうして形状に合わせられた上記の膜(6)を上記の成形用鋳型(7)に当がったまま冷却し、
− そして上記の膜を成形用鋳型(7)から取り外す方法において、
− 上記の膜(1)が、上記物品(6)の形状に合わせる前まで熱的に安定しない発泡ポリテトラフルオロエチレンで作製され、この膜(1)の繊維(3)が選択方位を有さず、
− 上記の膜(1)を、上記の物品(6)の形状に合わせたまま、上記の発泡ポリテトラフルオロエチレンのゲル化点以上の温度まで加熱することを特徴とする血液適合性物品の製造方法。 - 上記の膜が熱気で加熱されることを特徴とする請求項1に記載した血液適合性物品の製造方法。
- 上記の膜(1)が約400℃の温度まで加熱されることを特徴とする請求項1あるいは2に記載した血液適合性物品の製造方法。
- 上記の加熱された膜(1)が真空により上記の成形用鋳型(7)に当てがわれることを特徴とする請求項1〜3のいずれか1項に記載した血液適合性物品の製造方法。
- 上記の形状に合わせられた膜が急速冷却されることを特徴とする請求項1〜4のいずれか1項に記載した血液適合性物品の製造方法。
- 上記の形状を有する移植可能な人工器官あるいは人工器官の一部のための被膜(コーティング)(6)を形成しなければならない、複合形状の血液適合性物品を製造するために実施され、上記の人工器官あるいは人工器官の一部の形状に合わせた膜を上記の成形用鋳型(7)から取り外した後、この膜を人口装具あるいは人工器官の一部に接合させることを特徴とする前記請求項1〜5のいずれか1項に記載した血液適合性物品の製造方法。
- 上記の形状に合わせられた膜を上記の人工器官あるいはその一部(4)に接合するため、この膜を類似の形状の膨張可能な器具(11)に取り付け、この膜を少なくとも1層の接着剤を介して人工器官あるいはその一部と接触させた後、上記の器具(11)を膨張させて上記の接着剤層を圧縮し、確実に均一な厚さを有するようにすることを特徴とする請求項6に記載した血液適合性物品の製造方法。
- シリコンのようなエラストマにより人工器官あるいは人工器官の一部に接合させることを特徴とする請求項6あるいは7に記載した血液適合性物品の製造方法。
- 上記の人工心臓の少なくともその一部は、請求項1から8のいずれか1項に記載した方法を実施して形成された血液適合性被膜を有することを特徴とする人工心臓。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0703339A FR2915903B1 (fr) | 2007-05-10 | 2007-05-10 | Procede pour la realisation d'un objet hemocompatible de configuration complexe et objet ainsi obtenu. |
FR0703339 | 2007-05-10 | ||
PCT/FR2008/000607 WO2008145870A2 (fr) | 2007-05-10 | 2008-04-28 | Procede pour la realisation d'un objet hemocompatible de configuration complexe et objet ainsi obtenu |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010526573A true JP2010526573A (ja) | 2010-08-05 |
JP5427777B2 JP5427777B2 (ja) | 2014-02-26 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2010506963A Active JP5427777B2 (ja) | 2007-05-10 | 2008-04-28 | 複合形状の血液適合性物品の製造方法とこれにより得られた物品 |
Country Status (14)
Country | Link |
---|---|
US (1) | US8728264B2 (ja) |
EP (1) | EP1992369B1 (ja) |
JP (1) | JP5427777B2 (ja) |
KR (1) | KR101476160B1 (ja) |
CN (1) | CN101711169A (ja) |
AU (1) | AU2008257275B2 (ja) |
CA (1) | CA2686444C (ja) |
DK (1) | DK1992369T3 (ja) |
ES (1) | ES2542351T3 (ja) |
FR (1) | FR2915903B1 (ja) |
PL (1) | PL1992369T3 (ja) |
RU (1) | RU2430744C2 (ja) |
WO (1) | WO2008145870A2 (ja) |
ZA (1) | ZA200907664B (ja) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
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US8579964B2 (en) | 2010-05-05 | 2013-11-12 | Neovasc Inc. | Transcatheter mitral valve prosthesis |
US9554897B2 (en) | 2011-04-28 | 2017-01-31 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US9572665B2 (en) | 2013-04-04 | 2017-02-21 | Neovasc Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
EP3407835A4 (en) | 2016-01-29 | 2019-06-26 | Neovasc Tiara Inc. | PROSTHETIC VALVE FOR AVOIDING OBSTRUCTION PREVENTING FLOW |
CN109996581B (zh) | 2016-11-21 | 2021-10-15 | 内奥瓦斯克迪亚拉公司 | 用于快速收回经导管心脏瓣膜递送系统的方法和系统 |
EP3672530A4 (en) | 2017-08-25 | 2021-04-14 | Neovasc Tiara Inc. | SEQUENTIALLY INSERTED TRANSCATHETER MITRAL VALVE PROSTHESIS |
WO2020093172A1 (en) | 2018-11-08 | 2020-05-14 | Neovasc Tiara Inc. | Ventricular deployment of a transcatheter mitral valve prosthesis |
CA3126690A1 (en) | 2019-01-15 | 2020-07-23 | Palziv Ein Hanaziv Agricultural Cooperative Society Ltd. | Continuous open foam polymer sheet method |
CA3135753C (en) | 2019-04-01 | 2023-10-24 | Neovasc Tiara Inc. | Controllably deployable prosthetic valve |
CN113924065A (zh) | 2019-04-10 | 2022-01-11 | 内奥瓦斯克迪亚拉公司 | 具有自然血流的假体瓣膜 |
AU2020279750B2 (en) | 2019-05-20 | 2023-07-13 | Neovasc Tiara Inc. | Introducer with hemostasis mechanism |
WO2020257643A1 (en) | 2019-06-20 | 2020-12-24 | Neovasc Tiara Inc. | Low profile prosthetic mitral valve |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US4473423A (en) * | 1982-05-03 | 1984-09-25 | University Of Utah | Artificial heart valve made by vacuum forming technique |
WO1996016601A1 (en) * | 1994-11-30 | 1996-06-06 | W.L. Gore & Associates, Inc. | Surgical device for protecting organs from formation of adhesions |
US6440164B1 (en) * | 1999-10-21 | 2002-08-27 | Scimed Life Systems, Inc. | Implantable prosthetic valve |
US20040210307A1 (en) * | 2003-04-18 | 2004-10-21 | Alexander Khairkhahan | Percutaneous transcatheter heart valve replacement |
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US8257431B2 (en) * | 2006-11-01 | 2012-09-04 | Boston Scientific Scimed, Inc. | Multi-furcated ePTFE grafts and stent-graft prostheses and methods of making the same |
-
2007
- 2007-05-10 FR FR0703339A patent/FR2915903B1/fr active Active
-
2008
- 2008-04-28 CA CA 2686444 patent/CA2686444C/fr active Active
- 2008-04-28 WO PCT/FR2008/000607 patent/WO2008145870A2/fr active Application Filing
- 2008-04-28 KR KR1020097025669A patent/KR101476160B1/ko active IP Right Grant
- 2008-04-28 ES ES08290405.3T patent/ES2542351T3/es active Active
- 2008-04-28 AU AU2008257275A patent/AU2008257275B2/en active Active
- 2008-04-28 CN CN200880015494A patent/CN101711169A/zh active Pending
- 2008-04-28 JP JP2010506963A patent/JP5427777B2/ja active Active
- 2008-04-28 DK DK08290405.3T patent/DK1992369T3/en active
- 2008-04-28 EP EP20080290405 patent/EP1992369B1/fr active Active
- 2008-04-28 PL PL08290405T patent/PL1992369T3/pl unknown
- 2008-04-28 US US12/599,501 patent/US8728264B2/en active Active
- 2008-04-28 RU RU2009145704A patent/RU2430744C2/ru active
-
2009
- 2009-11-02 ZA ZA200907664A patent/ZA200907664B/xx unknown
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US4473423A (en) * | 1982-05-03 | 1984-09-25 | University Of Utah | Artificial heart valve made by vacuum forming technique |
WO1996016601A1 (en) * | 1994-11-30 | 1996-06-06 | W.L. Gore & Associates, Inc. | Surgical device for protecting organs from formation of adhesions |
US6440164B1 (en) * | 1999-10-21 | 2002-08-27 | Scimed Life Systems, Inc. | Implantable prosthetic valve |
US20040210307A1 (en) * | 2003-04-18 | 2004-10-21 | Alexander Khairkhahan | Percutaneous transcatheter heart valve replacement |
Also Published As
Publication number | Publication date |
---|---|
CA2686444C (fr) | 2014-07-15 |
KR101476160B1 (ko) | 2014-12-24 |
ZA200907664B (en) | 2010-07-28 |
RU2009145704A (ru) | 2011-06-20 |
CN101711169A (zh) | 2010-05-19 |
FR2915903A1 (fr) | 2008-11-14 |
JP5427777B2 (ja) | 2014-02-26 |
CA2686444A1 (fr) | 2008-12-04 |
EP1992369A1 (fr) | 2008-11-19 |
US8728264B2 (en) | 2014-05-20 |
EP1992369B1 (fr) | 2015-05-06 |
US20110244246A1 (en) | 2011-10-06 |
AU2008257275A1 (en) | 2008-12-04 |
RU2430744C2 (ru) | 2011-10-10 |
KR20100017723A (ko) | 2010-02-16 |
WO2008145870A3 (fr) | 2009-02-19 |
DK1992369T3 (en) | 2015-07-20 |
AU2008257275B2 (en) | 2013-09-26 |
PL1992369T3 (pl) | 2015-10-30 |
WO2008145870A8 (fr) | 2009-08-06 |
FR2915903B1 (fr) | 2010-06-04 |
WO2008145870A2 (fr) | 2008-12-04 |
ES2542351T3 (es) | 2015-08-04 |
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