JP6778693B2 - 繊維補強弁尖を有する人工心臓弁 - Google Patents
繊維補強弁尖を有する人工心臓弁 Download PDFInfo
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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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- 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
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- 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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
-
- 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
-
- 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
-
- 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
- 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)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
Description
例6は、第1のハードセグメント部分および第2のハードセグメント部分がそれぞれメチレンジイソシアネートおよびブタンジオールから作製されている、例5の人工心臓弁弁尖である。
例8は、ソフトセグメント部分が少なくともポリエーテル、フッ素化ポリエーテル、フルオロポリマー、ポリエステル、ポリアクリレート、ポリメタクリレート、ポリシロキサン、フッ素化ポリシロキサンまたはポリカーボネートをさらに含む、例5〜7のうちの1つの人工心臓弁弁尖である。
例12は、ヒドロゲルコーティングがポリエチレングリコール(PEG)を含む、例11の人工心臓弁弁尖である。
Xは、モノマーの繰返し単位への共有結合点であり、
各Rは、C1〜C4アルキル、特にメチルから独立して選択され、
nおよびmは、それぞれ1〜8の整数であり、
Yは、COO−、SO3−、O−SO3−、O−PO3−およびPO3−から選択されるアニオン基であり、かつ、
Zは、脂肪族アミンもしくは芳香族アミン、アミジン、グアニジンまたは第4級アミンから導出されるカチオン基、特にNR’3+であり、各R’は、C1〜C4アルキル、特にメチルから独立して選択される。
本明細書に示す方法は、1種または複数種の複合材料から作製された、本明細書に記載する人工心臓弁弁尖等の医療デバイスを形成するために使用され得る。特に、本明細書に示す方法は、多段弾性特性を有する、本明細書に記載する複合材料のうちの少なくとも1つを用いた弁尖を形成するために使用され得る。場合により、弁尖を形成する方法は、マンドレル上に第1のポリマー層を配置するステップを含む。場合により、弁尖を形成する方法は、複数の波状部を有する複数の繊維を、本明細書で考察する第1のポリマー層上に配置するステップを含む。場合により、弁尖を形成する方法は、本明細書で考察する複数の繊維上に第2のポリマー層を配置するステップを含む。
Claims (11)
- 繊維複合材料を含む人工心臓弁弁尖であって、前記繊維複合材料は、少なくとも部分的にポリマーマトリックスに組み込まれた複数のエレクトロスピニング繊維を含み、前記複数のエレクトロスピニング繊維が第1のポリイソブチレンウレタンコポリマーを含み、前記ポリマーマトリックスが第2のポリイソブチレンウレタンコポリマーを含み、
前記第1のポリイソブチレンウレタンコポリマーは、ハードセグメント部分およびソフトセグメント部分を有し、かつ第1の所定平均重量パーセントのハードセグメント部分を有し、
前記第2のポリイソブチレンウレタンコポリマーは、ハードセグメント部分およびソフトセグメント部分を有し、かつ第2の所定平均重量パーセントのハードセグメント部分を有し、
前記第1の所定平均重量パーセントが前記第2の所定平均重量パーセントより大きいことを特徴とする人工心臓弁弁尖。 - 前記第2のポリイソブチレンウレタンコポリマーが、約55Dのデュロメータ硬さを有する、請求項1に記載の人工心臓弁弁尖。
- 人工心臓弁の管状体に結合された少なくとも2つの人工心臓弁弁尖のうちの1つである、請求項1に記載の人工心臓弁弁尖。
- 前記第1のポリイソブチレンウレタンコポリマーのハードセグメント部分および前記第2のポリイソブチレンウレタンコポリマーのハードセグメント部分の各々がメチレンジイソシアネートおよびブタンジオールから作製されている、請求項1に記載の人工心臓弁弁尖。
- ソフトセグメント部分がポリイソブチレンジオールまたはポリイソブチレンジアミンの残留モノマーから作製されている、請求項1に記載の人工心臓弁弁尖。
- ソフトセグメント部分が少なくともポリエーテル、フッ素化ポリエーテル、フルオロポリマー、ポリエステル、ポリアクリレート、ポリメタクリレート、ポリシロキサン、フッ素化ポリシロキサンまたはポリカーボネートをさらに含む、請求項1に記載の人工心臓弁弁尖。
- 弁尖の表面上にヒドロゲルコーティングをさらに備える、請求項1〜6のいずれか一項に記載の人工心臓弁弁尖。
- 前記ヒドロゲルコーティングがポリエチレングリコール(PEG)を含む、請求項7に記載の人工心臓弁弁尖。
- 前記複数のエレクトロスピニング繊維の第1の部分が第1の所定配向を有し、前記複数のエレクトロスピニング繊維の第2の部分が第2の所定配向を有し、前記第1の所定配向が前記第2の所定配向と異なる、請求項1〜8のいずれか一項に記載の人工心臓弁弁尖。
- 前記第1のポリイソブチレンウレタンコポリマーおよび前記第2のポリイソブチレンウレタンコポリマーがそれぞれ約2:1のメチレンジイソシアネートおよびブタンジオールの比を使用して作製されている、請求項4に記載の人工心臓弁弁尖。
- 請求項1〜10のいずれか一項に記載の人工心臓弁弁尖を作製する方法であって、
マンドレル上に前記複数のエレクトロスピニング繊維を配置するステップと、
前記マンドレル上に前記ポリマーマトリックスの層を配置するステップと
を含む方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US201562145380P | 2015-04-09 | 2015-04-09 | |
US62/145,380 | 2015-04-09 | ||
US15/082,382 | 2016-03-28 | ||
US15/082,382 US10314696B2 (en) | 2015-04-09 | 2016-03-28 | Prosthetic heart valves having fiber reinforced leaflets |
PCT/US2016/024753 WO2016164209A1 (en) | 2015-04-09 | 2016-03-29 | Prosthetic heart valves having fiber reinforced leaflets |
Publications (2)
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JP2018516610A JP2018516610A (ja) | 2018-06-28 |
JP6778693B2 true JP6778693B2 (ja) | 2020-11-04 |
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JP2017549776A Active JP6778693B2 (ja) | 2015-04-09 | 2016-03-29 | 繊維補強弁尖を有する人工心臓弁 |
Country Status (5)
Country | Link |
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US (2) | US10314696B2 (ja) |
EP (1) | EP3280358B1 (ja) |
JP (1) | JP6778693B2 (ja) |
CN (1) | CN107405426B (ja) |
WO (1) | WO2016164209A1 (ja) |
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2016
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- 2016-03-29 CN CN201680018663.3A patent/CN107405426B/zh active Active
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US20190262131A1 (en) | 2019-08-29 |
CN107405426A (zh) | 2017-11-28 |
US20160296323A1 (en) | 2016-10-13 |
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