CN116251238B - 具有三层结构的仿生瓣膜瓣叶及其制造方法 - Google Patents
具有三层结构的仿生瓣膜瓣叶及其制造方法 Download PDFInfo
- Publication number
- CN116251238B CN116251238B CN202310175450.3A CN202310175450A CN116251238B CN 116251238 B CN116251238 B CN 116251238B CN 202310175450 A CN202310175450 A CN 202310175450A CN 116251238 B CN116251238 B CN 116251238B
- Authority
- CN
- China
- Prior art keywords
- fabric
- layer
- viscoelastic material
- valve leaflet
- flexible
- Prior art date
- 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.)
- Active
Links
- 239000011664 nicotinic acid Substances 0.000 title claims abstract description 19
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 7
- 239000010410 layer Substances 0.000 claims abstract description 78
- 239000004744 fabric Substances 0.000 claims abstract description 62
- 239000003190 viscoelastic substance Substances 0.000 claims abstract description 42
- 239000002344 surface layer Substances 0.000 claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 11
- 238000009941 weaving Methods 0.000 claims abstract description 7
- 229920002635 polyurethane Polymers 0.000 claims description 11
- 239000004814 polyurethane Substances 0.000 claims description 11
- 239000000203 mixture Substances 0.000 claims description 9
- 239000000835 fiber Substances 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- 229920000728 polyester Polymers 0.000 claims description 8
- 102000008186 Collagen Human genes 0.000 claims description 7
- 108010035532 Collagen Proteins 0.000 claims description 7
- 229920001436 collagen Polymers 0.000 claims description 7
- -1 polypropylene Polymers 0.000 claims description 7
- 102000016942 Elastin Human genes 0.000 claims description 6
- 108010014258 Elastin Proteins 0.000 claims description 6
- 229920002549 elastin Polymers 0.000 claims description 6
- 229920002683 Glycosaminoglycan Polymers 0.000 claims description 5
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 5
- 238000005266 casting Methods 0.000 claims description 5
- 238000007598 dipping method Methods 0.000 claims description 5
- 229920000570 polyether Polymers 0.000 claims description 5
- 230000003139 buffering effect Effects 0.000 claims description 4
- 238000013329 compounding Methods 0.000 claims description 4
- 241001061264 Astragalus Species 0.000 claims description 3
- 239000004705 High-molecular-weight polyethylene Substances 0.000 claims description 3
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 claims description 3
- 239000004760 aramid Substances 0.000 claims description 3
- 229920003235 aromatic polyamide Polymers 0.000 claims description 3
- 235000006533 astragalus Nutrition 0.000 claims description 3
- 230000003592 biomimetic effect Effects 0.000 claims description 3
- 239000003822 epoxy resin Substances 0.000 claims description 3
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 claims description 3
- 239000002657 fibrous material Substances 0.000 claims description 3
- 150000004676 glycans Chemical class 0.000 claims description 3
- 229920000126 latex Polymers 0.000 claims description 3
- 239000004816 latex Substances 0.000 claims description 3
- 229920000647 polyepoxide Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 229920001282 polysaccharide Polymers 0.000 claims description 3
- 239000005017 polysaccharide Substances 0.000 claims description 3
- 229920002379 silicone rubber Polymers 0.000 claims description 3
- 210000004233 talus Anatomy 0.000 claims description 3
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 claims description 3
- 238000009940 knitting Methods 0.000 claims description 2
- 238000005507 spraying Methods 0.000 claims description 2
- 238000009965 tatting Methods 0.000 claims description 2
- 229920001817 Agar Polymers 0.000 claims 1
- 239000011248 coating agent Substances 0.000 abstract description 10
- 238000000576 coating method Methods 0.000 abstract description 10
- 230000015556 catabolic process Effects 0.000 abstract description 6
- 238000006731 degradation reaction Methods 0.000 abstract description 6
- 239000002861 polymer material Substances 0.000 abstract description 6
- 210000003709 heart valve Anatomy 0.000 abstract description 5
- 229920006237 degradable polymer Polymers 0.000 abstract description 3
- 238000004132 cross linking Methods 0.000 description 15
- 239000000243 solution Substances 0.000 description 12
- 230000000052 comparative effect Effects 0.000 description 8
- 238000011282 treatment Methods 0.000 description 6
- 239000002759 woven fabric Substances 0.000 description 5
- 239000004677 Nylon Substances 0.000 description 4
- 239000002131 composite material Substances 0.000 description 4
- 210000004379 membrane Anatomy 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 229920001778 nylon Polymers 0.000 description 4
- 239000004945 silicone rubber Substances 0.000 description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- 229920002385 Sodium hyaluronate Polymers 0.000 description 3
- 238000013016 damping Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 229940010747 sodium hyaluronate Drugs 0.000 description 3
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 3
- PEVRKKOYEFPFMN-UHFFFAOYSA-N 1,1,2,3,3,3-hexafluoroprop-1-ene;1,1,2,2-tetrafluoroethene Chemical compound FC(F)=C(F)F.FC(F)=C(F)C(F)(F)F PEVRKKOYEFPFMN-UHFFFAOYSA-N 0.000 description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 2
- 229920000936 Agarose Polymers 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 2
- 229920001661 Chitosan Polymers 0.000 description 2
- 108010022355 Fibroins Proteins 0.000 description 2
- 239000002033 PVDF binder Substances 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 125000004122 cyclic group Chemical group 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000003618 dip coating Methods 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 238000001523 electrospinning Methods 0.000 description 2
- 208000018578 heart valve disease Diseases 0.000 description 2
- 229920002529 medical grade silicone Polymers 0.000 description 2
- 210000003516 pericardium Anatomy 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920005995 polystyrene-polyisobutylene Polymers 0.000 description 2
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 235000010413 sodium alginate Nutrition 0.000 description 2
- 229940005550 sodium alginate Drugs 0.000 description 2
- 239000000661 sodium alginate Substances 0.000 description 2
- 238000009987 spinning Methods 0.000 description 2
- 229920001059 synthetic polymer Polymers 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonium chloride Substances [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 1
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 1
- 229920006052 Chinlon® Polymers 0.000 description 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229920002302 Nylon 6,6 Polymers 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 235000011114 ammonium hydroxide Nutrition 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 239000013043 chemical agent Substances 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000001723 curing Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 125000004386 diacrylate group Chemical group 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 229920005570 flexible polymer Polymers 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000009998 heat setting Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- ZFGMDIBRIDKWMY-PASTXAENSA-N heparin Chemical compound CC(O)=N[C@@H]1[C@@H](O)[C@H](O)[C@@H](COS(O)(=O)=O)O[C@@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O[C@H]2[C@@H]([C@@H](OS(O)(=O)=O)[C@@H](O[C@@H]3[C@@H](OC(O)[C@H](OS(O)(=O)=O)[C@H]3O)C(O)=O)O[C@@H]2O)CS(O)(=O)=O)[C@H](O)[C@H]1O ZFGMDIBRIDKWMY-PASTXAENSA-N 0.000 description 1
- 229960001008 heparin sodium Drugs 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000002121 nanofiber Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000671 polyethylene glycol diacrylate Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
Classifications
-
- 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
-
- 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
-
- 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
- A61L27/18—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
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
-
- 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
-
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- 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
-
- 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
- Y02W90/00—Enabling technologies or technologies with a potential or indirect contribution to greenhouse gas [GHG] emissions mitigation
- Y02W90/10—Bio-packaging, e.g. packing containers made from renewable resources or bio-plastics
Abstract
本发明属于人工瓣膜技术领域,尤指一种具有三层结构的仿生瓣膜瓣叶及其制造方法。该瓣叶包括:织物层,为采用不可降解的高强柔性织物编制而成的网状结构;粘弹材料层,在织物表面、织物间隙处吸收瓣叶运动的冲击力;柔性面层,包覆织物层与粘弹材料层,采用不可降解的聚合物材料。其制造步骤包括:织造不可降解的高强柔性织物;高强柔性织物的织物表面、织物间隙处覆盖粘弹材料;在粘弹材料的外层覆盖不可降解的柔性聚合物材料。该仿生瓣膜瓣叶的力学性能、耐疲劳性能和抗降解性能较生物瓣有显著提高,可作为人工心脏瓣膜使用。
Description
技术领域
本发明属于人工瓣膜技术领域,尤指一种具有三层结构的仿生瓣膜瓣叶及其制造方法。
背景技术
瓣膜性心脏病(valvularheart disease,VHD)是人类健康的主要杀手之一,全球每年有数百万人患病。目前,临床上的治疗方法包括药物治疗,瓣膜修复以及瓣膜置换。瓣膜置换包括机械瓣膜与生物瓣膜。人工心脏机械瓣膜具有较好的耐用性,但容易形成血栓,且患者术后需终生抗凝;植入生物瓣患者虽不用服药,但由于生物瓣会产生钙化、降解等问题,其使用寿命较短。
近年来,研究人员开始研究聚四氟乙烯,聚氨酯等生物相容性合成高分子材料在人工心脏瓣膜的应用。然而,现今的高分子人工瓣膜材料制备方法还存在材料力学性能达不到应用要求以及材料内皮化缓慢易产生血栓等问题。
天然的心脏动脉瓣膜小叶由三层结构构成,分别是弹性蛋白层(Elastin sheet),胶原纤维(Collagen fiber)以及糖胺葡聚糖层(Glycosaminolyca n)。每层结构分别承担了不同的作用:弹性蛋白层的弹性使瓣叶能够反复开闭(伸展-弯曲),同时其也能提供一定反冲力,加速瓣叶伸展状态下恢复到弯曲状态,从而减少瓣叶反流;胶原纤维层中的取向胶原纤维束起到约束瓣叶运动,提供支撑力的作用;糖胺葡聚糖层吸水膨胀,可以吸收瓣叶运动的冲击力,起到缓冲的作用。
郭峰等(郭峰,刘唱,韩日峥,等.仿生各向异性高分子人工瓣膜制备及性能研究[J].中国科学:材料科学(英文版),2020,63(4):15.)采用静电纺丝法利用丝素蛋白、聚乙二醇二丙烯酸酯(poly(ethylene glycol)diacrylate,PEGDA)水凝胶复合制备了具有力学各向异性特征人体心脏瓣膜,使其能够承受长期的开合循环负荷。作为人工高分子瓣膜材料使用。但是由于丝素在生物体内会发生水解与酶解,并会伴随较大强力损失,因此不具备临床实用前景。
发明内容
在一方面,本发明提供一种具有三层结构的仿生瓣膜瓣叶,该仿生瓣膜瓣叶的力学性能、耐疲劳性能和抗降解性能较生物瓣有显著提高,可作为人工心脏瓣膜使用。
为了实现上述目的,本发明所采用的技术方案如下:
一种具有三层结构的仿生瓣膜瓣叶,包括:
织物层,为采用不可降解的高强柔性织物编制而成的网状结构;
粘弹材料层,在织物表面、织物间隙处吸收瓣叶运动的冲击力;
柔性面层,包覆织物层与粘弹材料层,采用不可降解的聚合物材料。
一些技术方案中,所述粘弹材料层的组成包括:海藻酸钠、透明质酸钠、黄芪多糖、壳聚糖、琼脂多糖、医用乳胶及环氧树脂中的一种或者多种。
一些技术方案中,所述柔性面层的组成包括:硅橡胶、聚酯型聚氨酯、聚醚性聚氨酯、聚四氟乙烯、全氟乙烯丙烯共聚物、聚偏氟乙烯及苯乙烯-异丁烯嵌段共聚物中的一种或者多种。
一些技术方案中,所述织物层的纤维材料组成包括:聚丙烯、聚酯、高分子量聚乙烯、超高分子量聚乙烯、芳纶、膨体聚四氟乙烯、聚酯型聚氨酯和聚醚性聚氨酯中的一种或者多种。
一些技术方案中,所述织物层的编制方式为梭织或针织;且
织物的纱线粗细度为10D~60D,厚度为30~100微米。
一些技术方案中,所述柔性面层模拟天然瓣叶中的弹性蛋白层,具有柔韧性;所述织物层模拟天然瓣叶中的胶原纤维,具备支撑力;所述粘弹材料层模拟天然瓣叶中的糖胺葡聚糖层,起到缓冲作用。
另一方面,本发明进一步提供上述仿生瓣膜瓣叶的制造方法,首先织造不可降解的高强柔性织物;然后在高强柔性织物的织物表面、织物间隙处覆盖粘弹材料;最后在粘弹材料的外层覆盖不可降解的柔性聚合物材料。制造出的仿生瓣叶具有高强度、抗拉伸、耐疲劳和不降解的特点。
为了实现上述目的,本发明所采用的技术方案如下:
一些技术方案中,所述的覆盖粘弹材料具体可通过浸渍、喷涂或浇铸的方式;和/或,
所述的覆盖不可降解的柔性聚合物材料具体可通过浸渍、浇铸或复合的方式。
一些技术方案中,粘弹材料在与织物结合后经过交联处理。
一些技术方案中,所述交联处理的方式包括:离子交联、化学试剂交联、紫外光交联、热交联和冷冻交联中的至少一种。
本发明采用以上技术方案至少具有如下的有益效果:
本申请提出的仿生瓣膜瓣叶具有三层结构,包括织物层、粘弹材料层和柔性面层,其中织物层采用高强柔性织物,可循环拉伸不变形,具有耐疲劳性;粘弹材料层覆盖至织物表面和织物间隙,可起到阻尼层作用;柔性面层采用聚合物材料,可以起到包覆粘弹材料层和织物层的作用,避免粘弹材料脱落降解,从而显著延长瓣膜的使用寿命。
附图说明
为了更清楚的说明本发明实施例中的技术方案,下面将对实施例中所需要使用的附图及其标记作简单的介绍,显而易见地,下面描述的附图仅仅是本发明的一些实施例,对于本领域的普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其它的附图。
图1为本发明实施例所述的具有三层结构仿生瓣膜瓣叶的结构示意图;
图2为本发明实施例中织物与粘弹材料层结合的结构示意图。
图中标注符号的含义如下:
1-柔性面层;2-粘弹材料层;3-织物层。
具体实施方式
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对照附图说明本发明的具体实施方式。显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图,并获得其他的实施方式。
为使图面简洁,各图中只示意性地表示出了与发明相关的部分,它们并不代表其作为产品的实际结构。另外,以使图面简洁便于理解,在有些图中具有相同结构或功能的部件,仅示意性地绘示了其中的一个,或仅标出了其中的一个。在本文中,“一个”不仅表示“仅此一个”,也可以表示“多于一个”的情形。
还应当进一步理解,在本申请说明书和所附权利要求书中使用的术语“和/或”是指相关联列出的项中的一个或多个的任何组合以及所有可能组合,并且包括这些组合。
参阅图1、图2,示出一种具有三层结构的仿生瓣膜瓣叶,包括:织物层3,为采用不可降解的高强柔性织物编制而成的网状结构;粘弹材料层2,在织物表面、织物间隙处吸收瓣叶运动的冲击力;柔性面层1,包覆织物层3与粘弹材料层2,采用不可降解的聚合物材料。
该实施方式中的柔性面层1模拟天然瓣叶中的弹性蛋白层,具有柔韧性;织物层3模拟天然瓣叶中的胶原纤维,具备支撑力;粘弹材料层2模拟天然瓣叶中的糖胺葡聚糖层,起到缓冲作用。
上述实施例中,织物为一种编织物,具有高强度与耐疲劳性,还具有良好的生物相容性以及生物不可降解性。编织物可为梭织或者针织结构;编织物的纤维材料组成可为聚丙烯、聚酯、高分子量聚乙烯、超高分子量聚乙烯、芳纶、膨体聚四氟乙烯、聚酯型聚氨酯和聚醚性聚氨酯中的一种或者多种;编织物的纱线粗细度10D~60D,织物的厚度30~100微米。
本案中的织物层3采用高强柔性织物,兼具强度与韧性,较佳的,可通过模拟瓣膜应力传导和应力耗散情况进行织物纤维的布置。
上述实施例中,粘弹材料层2可由浸渍、超声喷涂及浇铸中一种或者多种方式实现与织物层3的结合;粘弹材料层2的作用为充当阻尼层,像弹簧一样吸收瓣叶运动的振动能量,避免人工瓣叶的运动带来的应力过大,从而导致瓣膜破裂。
在一具体的实施方式中,粘弹材料的组成可以为海藻酸钠、透明质酸钠、黄芪多糖、壳聚糖及琼脂多糖等具有粘弹性的水溶性粘弹材料中的一种或者多种;也可以为医用乳胶、环氧树脂等非水溶性的合成高分子粘弹材料中的一种或者多种。
较佳的,水溶性粘弹材料在与织物结合后经过交联处理;交联处理的方式有离子交联、化学试剂交联、紫外光交联、热交联和冷冻交联等;交联处理是为了提升粘弹材料的抗降解性能,提升瓣膜的使用寿命。
上述实施例中,柔性面层1的组成包括:硅橡胶、聚酯型聚氨酯、聚醚性聚氨酯、聚四氟乙烯、全氟乙烯丙烯共聚物、聚偏氟乙烯及苯乙烯-异丁烯嵌段共聚物中的一种或者多种。
具体的,不可降解柔性面层可通过浸渍、浇铸及复合等一种或者多种方法实现;其作用在于增强瓣膜的柔韧性,同时保护中层的粘弹材料涂层不降解或者崩解。
为了对本申请制造的仿生瓣膜瓣叶的力学性能与耐疲劳性能进行表征,现设计如下实施例与对比例进行说明。
实施例1
织造PET机织物:织造聚对苯二甲酸乙二醇酯(PET)机织物:PET纱线50D,经向密度180根/inch,经向密度150根/inch,厚度约80微米;
涂覆粘弹材料:采用5%透明质酸钠(10kD)进行涂层,浸涂2次,然后使用EDC-NHS进行交联4小时,随后烘干,涂层厚度约2~3微米;
溶液电纺制备微载药纳米纤维膜:首先配制纺丝液,将TPU粒子完全溶解在N-N二甲基甲酰胺与二氯甲烷混合溶液中,并均匀加入约1mL的肝素钠溶液,随后将配制好的纺丝液加入针筒,并接上20~50kV的高压静电,溶液以2mL/hour速率推注,最后以接收装置接收,接收距离13~30cm,膜的厚度35微米;
内外层的复合:将制备好的粘弹涂层织物与4层TPU静电纺膜平整叠在一起,垂直方向施加2M Pa压力,并在80℃加热。然后停止加热,让膜自然冷却,最终厚度在120微米左右;
TPU复合膜的后处理:将制备好的复合膜通过切割及将之放于瓣膜成型模具热定型工艺加工成三叶瓣的形状。
实施例2
织造锦纶针织物:织造聚对锦纶(聚酰胺66)针织物:锦纶纱线60D,厚度约100微米;
涂覆粘弹材料:用天然乳胶/氨水溶液20%进行涂层,浸涂1次,然后使用硫化剂进行交联4小时,随后烘干,厚度约110um;
浇筑成膜:将医用硅橡胶组分A与组分B混合,消泡,倒在上述的带有粘弹涂层的锦纶针织物上,然后烘干固化,利用模具控制成型厚度,使最终的厚度为130um;
复合膜后处理:利用激光切割将上述的膜切成瓣叶二维展开后的形状,即可代替动物心包用于瓣膜的缝合。
对比例1
与实施例1大体相同,不同之处仅在于:取消中间粘弹材料层的设置。
对比例2
采用经过脱细胞与戊二醛处理的牛心包瓣叶进行对照,厚度为220~350微米。
表1各实施例与对比例所涉瓣叶的力学数据
其中,循环拉伸的测试方法为:将样品制成20mm×50mm的条状,以10HZ的频率,10mm的位移循环拉伸,直至材料发生断裂作为终点,整个过程材料均在水中进行。
试验结论:实施例1-2与对比例1的区别在于粘弹材料层的增设;实施例1-2与对比例2的区别在于本案为仿生瓣膜瓣叶,而对比例2为牛心包瓣叶。通过对比表1数据可知,各试验在断裂强度上没有较大差异,但是在断裂位移和拉伸循环次数上,本案实施例要明显高于对比例1-2,可见粘弹材料层2起到了阻尼层作用,提升了瓣叶的力学性能与耐疲劳性能。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明的保护范围应以所附权利要求为准。
本领域技术人员应当理解,虽然本发明是按照多个实施例的方式进行描述的,但是并非每个实施例仅包含一个独立的技术方案。说明书中如此叙述仅仅是为了清楚起见,本领域技术人员应当将说明书作为一个整体加以理解,并将各实施例中所涉及的技术方案看作是可以相互组合成不同实施例的方式来理解本发明的保护范围。
Claims (6)
1.一种具有三层结构的仿生瓣膜瓣叶,其特征在于,包括:
织物层,为采用高强柔性织物编制而成的网状结构,所述织物层的纤维材料组成包括:聚丙烯、聚酯、高分子量聚乙烯、超高分子量聚乙烯、芳纶、膨体聚四氟乙烯、聚酯型聚氨酯和聚醚型聚氨酯中的一种或者多种;
粘弹材料层,在织物表面、织物间隙处吸收瓣叶运动的冲击力,所述粘弹材料层的组成包括:黄芪多糖、琼脂多糖、医用乳胶及环氧树脂中的一种或者多种;
柔性面层,包覆织物层与粘弹材料层,所述柔性面层的组成为硅橡胶。
2.根据权利要求1所述的具有三层结构的仿生瓣膜瓣叶,其特征在于,
所述织物层的编制方式为梭织或针织;且
织物的纱线粗细度为10D~60D,厚度为30~100微米。
3.根据权利要求1或2所述的具有三层结构的仿生瓣膜瓣叶,其特征在于,
所述柔性面层模拟天然瓣叶中的弹性蛋白层,具有柔韧性;
所述织物层模拟天然瓣叶中的胶原纤维,具备支撑力;
所述粘弹材料层模拟天然瓣叶中的糖胺葡聚糖层,起到缓冲作用。
4.如权利要求1-3任一所述的仿生瓣膜瓣叶的制造方法,其特征在于,
包括步骤:
织造不可降解的高强柔性织物;
在高强柔性织物的织物表面、织物间隙处覆盖粘弹材料;
在粘弹材料的外层覆盖不可降解的柔性聚合物材料。
5.根据权利要求4所述的制造方法,其特征在于,
所述的覆盖粘弹材料具体可通过浸渍、喷涂或浇铸的方式;和/或,
所述的覆盖不可降解的柔性聚合物材料具体可通过浸渍、浇铸或复合的方式。
6.根据权利要求4所述的制造方法,其特征在于,
粘弹材料在与织物结合后经过交联处理。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310175450.3A CN116251238B (zh) | 2023-02-28 | 2023-02-28 | 具有三层结构的仿生瓣膜瓣叶及其制造方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310175450.3A CN116251238B (zh) | 2023-02-28 | 2023-02-28 | 具有三层结构的仿生瓣膜瓣叶及其制造方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN116251238A CN116251238A (zh) | 2023-06-13 |
CN116251238B true CN116251238B (zh) | 2023-11-21 |
Family
ID=86685962
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202310175450.3A Active CN116251238B (zh) | 2023-02-28 | 2023-02-28 | 具有三层结构的仿生瓣膜瓣叶及其制造方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN116251238B (zh) |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6585767B1 (en) * | 1998-11-23 | 2003-07-01 | Agion Technologies, Inc. | Antimicrobial suturing ring for heart valve |
CN105007955A (zh) * | 2013-03-13 | 2015-10-28 | W.L.戈尔及同仁股份有限公司 | 适用于植入物的耐用高强度聚合物复合材料及其制品 |
CN106668949A (zh) * | 2011-04-01 | 2017-05-17 | W.L.戈尔及同仁股份有限公司 | 适用于植入物的耐用高强度聚合物复合材料及其制品 |
CN112972770A (zh) * | 2021-02-22 | 2021-06-18 | 南通纺织丝绸产业技术研究院 | 一种复合增强结构人工心脏瓣膜及制备方法 |
WO2021251974A1 (en) * | 2020-06-11 | 2021-12-16 | Abbott Laboratories | Fabric material for medical devices |
CN113893063A (zh) * | 2021-09-24 | 2022-01-07 | 宁波健世科技股份有限公司 | 一种纤维增强的仿生高分子瓣叶及其制造方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2015169870A1 (en) * | 2014-05-06 | 2015-11-12 | Dsm Ip Assets B.V. | Method of making a prosthetic valve and valve obtained therewith |
US10080652B2 (en) * | 2015-03-13 | 2018-09-25 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having an improved tubular seal |
US20210121290A1 (en) * | 2019-10-24 | 2021-04-29 | Abbott Laboratories | Sheet material for medical devices |
US20220395614A1 (en) * | 2019-12-26 | 2022-12-15 | The Trustees Of Columbia University In The City Of New York | Biomimetic polymeric composite for heart valve repair |
-
2023
- 2023-02-28 CN CN202310175450.3A patent/CN116251238B/zh active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6585767B1 (en) * | 1998-11-23 | 2003-07-01 | Agion Technologies, Inc. | Antimicrobial suturing ring for heart valve |
CN106668949A (zh) * | 2011-04-01 | 2017-05-17 | W.L.戈尔及同仁股份有限公司 | 适用于植入物的耐用高强度聚合物复合材料及其制品 |
CN105007955A (zh) * | 2013-03-13 | 2015-10-28 | W.L.戈尔及同仁股份有限公司 | 适用于植入物的耐用高强度聚合物复合材料及其制品 |
WO2021251974A1 (en) * | 2020-06-11 | 2021-12-16 | Abbott Laboratories | Fabric material for medical devices |
CN112972770A (zh) * | 2021-02-22 | 2021-06-18 | 南通纺织丝绸产业技术研究院 | 一种复合增强结构人工心脏瓣膜及制备方法 |
CN113893063A (zh) * | 2021-09-24 | 2022-01-07 | 宁波健世科技股份有限公司 | 一种纤维增强的仿生高分子瓣叶及其制造方法 |
Non-Patent Citations (2)
Title |
---|
无支架心包组织工程二尖瓣的研制与临床应用;龚光甫;胡建国;;医学研究通讯(06);全文 * |
组织工程心脏瓣膜:结构及支架的研究与进展;陈锐;柯勤飞;莫秀梅;何创龙;王红声;;中国组织工程研究与临床康复(23);全文 * |
Also Published As
Publication number | Publication date |
---|---|
CN116251238A (zh) | 2023-06-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11696972B2 (en) | Process for the production of a hybrid structure consisting of coupled silk fibroin microfibers and nanofibers, hybrid structure thus obtained and its use as implantable medical device | |
US10219895B2 (en) | Nanofiber-based graft for heart valve replacement and methods of using the same | |
Bracaglia et al. | Extracellular matrix‐based biohybrid materials for engineering compliant, matrix‐dense tissues | |
Xie et al. | The mechanical performance of weft-knitted/electrospun bilayer small diameter vascular prostheses | |
US20230158204A1 (en) | Anti-fouling implantable material and method of making | |
JP2023538510A (ja) | ポリウレタン複合シート、そのような複合シートの製造方法及びその医療用留置具の製造における使用 | |
El-Ghazali et al. | An overview of medical textile materials | |
CN113878955B (zh) | 一种多层复合的仿生高分子瓣叶及其制造方法 | |
Wang et al. | Novel nanofiber‐based material for endovascular scaffolds | |
CN116251238B (zh) | 具有三层结构的仿生瓣膜瓣叶及其制造方法 | |
CN219538592U (zh) | 具有三层结构的仿生瓣膜瓣叶 | |
US20200129665A1 (en) | Novel nanofiber-based grafts and methods of making and using the same | |
CN113388950A (zh) | 一种可吸收高性能纳米纤维机织肌腱补片及其制备方法 | |
US20220151758A1 (en) | Bio-functionalized prosthetic structure with core-shell architecture for partial or total repair of human tendons or ligaments | |
US20190231534A1 (en) | A biomimetic functional and regenerative cartilage implant | |
CN219538593U (zh) | 一种纺织基增强的复合瓣叶 | |
Zhou et al. | Mechanical behaviors of high-strength fabric composite membrane designed for cardiac valve prosthesis replacement | |
Salehi et al. | Medical textiles as substrates for tissue engineering | |
Polyester | 4. TEXTILES FOR IMPLANTATION | |
WO2023110744A1 (en) | Composite sheets and medical implants comprising such sheets | |
TEKIN | Development of Hybrid Braided Vascular Prostheses | |
Cheung | Animal-Based Fiber-Reinforced Biocomposites |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant |