WO2020057414A1 - Valve cardiaque biologique sèche capable d'absorber rapidement de l'eau et de s'aplatir, et son procédé de préparation - Google Patents

Valve cardiaque biologique sèche capable d'absorber rapidement de l'eau et de s'aplatir, et son procédé de préparation Download PDF

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WO2020057414A1
WO2020057414A1 PCT/CN2019/105361 CN2019105361W WO2020057414A1 WO 2020057414 A1 WO2020057414 A1 WO 2020057414A1 CN 2019105361 W CN2019105361 W CN 2019105361W WO 2020057414 A1 WO2020057414 A1 WO 2020057414A1
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Prior art keywords
heart valve
biological heart
aqueous solution
dry biological
preparing
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PCT/CN2019/105361
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English (en)
Chinese (zh)
Inventor
王云兵
雷洋
李高参
杨立
林浩昇
邝大军
余金城
Original Assignee
杭州启明医疗器械股份有限公司
四川大学
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Publication of WO2020057414A1 publication Critical patent/WO2020057414A1/fr

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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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3625—Vascular tissue, e.g. heart valves
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • 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
    • 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
    • A61L2430/40—Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking

Definitions

  • the invention relates to the field of medical materials and medical devices, and in particular, to a dry biological heart valve capable of quickly absorbing and flattening, and a preparation method thereof.
  • Heart valve disease is a common valvular disease. Anatomically manifested as narrowed blood passages or valvular insufficiency. Treatment of heart valve disease includes thoracotomy and percutaneous heart valve replacement. Thoracic surgery is very traumatic, high risk, slow recovery, and requires extracorporeal circulation support, which is unacceptable to many patients. Percutaneous heart valve replacement surgery has become the main trend of future valve surgery because it has less trauma to patients and low risk. Biological heart valves are a class of biomedical materials used to replace heart valves in humans. Biological heart valves are generally prepared by cross-linking glutaraldehyde from porcine pericardium and bovine pericardium.
  • the existing interventional biological valve is generally cross-linked by glutaraldehyde, and then the biological valve is sewn on a metal stent, and then stored in a glutaraldehyde solution.
  • glutaraldehyde Prior to interventional valve replacement surgery, multiple washing, crimping, and assembly steps are required. This preparation process is cumbersome and easily leads to an increased risk of surgery.
  • the biological valve stored in the glutaraldehyde solution for a long time can easily lead to the residual of glutaraldehyde and increase the calcification and toxicity of the biological valve. Therefore, the development of the biological valve into a dry film stored away from the glutaraldehyde solution and pre-loading in the valve delivery system can better solve the above problems.
  • the dry biological valve pre-loaded in the valve delivery system is subject to a longer period of mechanical compression, and because of the higher requirements for the rapid water absorption and self-healing performance of the biological valve in the dry state, the existing Biological valves cannot absorb water quickly and flatten.
  • an object of the present invention is to provide a dry biological heart valve that can absorb water quickly and flatten, and a preparation method thereof, which aims to solve the problem that existing interventional biological valves need to be stored in glutaraldehyde solution and cannot be used. It is pre-loaded in the conveying system, needs to be temporarily cleaned and pressed, and cannot be quickly absorbed and flattened.
  • the invention provides a method for preparing a dry biological heart valve that can absorb water quickly and flatten, comprising the steps of: cross-linking an animal pericardium with an aqueous solution of glutaraldehyde, and then immersing the solution in an extracellular matrix biological enzyme solution , And finally dried to obtain a dry biological heart valve that can absorb and flatten quickly.
  • the method for preparing a rapidly absorbable and flattened dry biological heart valve wherein the extracellular matrix biological enzyme aqueous solution is one or more of collagenase, elastase, hyaluronidase, and chondroitin sulfate mixture.
  • the concentration of the extracellular matrix biological enzyme aqueous solution is 0.1-50 U / ml.
  • the method for preparing a rapidly absorbable and flattened dry biological heart valve wherein the animal pericardium after cross-linking treatment is immersed in an extracellular matrix biological enzyme aqueous solution under a shaking condition of 25 to 37 ° C for 12 to 72 hours. .
  • the volume concentration of the glutaraldehyde aqueous solution is 0.1 to 5%, and the pH is 7 to 8.
  • the animal pericardium is crosslinked and treated with an aqueous solution of glutaraldehyde under shaking conditions of 20 to 45 ° C for 1 to 7 days.
  • the method for preparing a quick-absorbing and flattening dry biological heart valve wherein the drying refers to dehydration drying in an alcohol solvent.
  • the dehydration and drying adopts dehydration and drying of a gradient concentration alcohol mixed solvent.
  • the method for preparing a rapidly absorbable and flattened dry biological heart valve wherein the alcohol solvents include methanol, ethanol, n-propanol, isopropanol, glycerol, n-butanol, n-pentanol, n- One or more of undecanol, n-dodecanol, 2-propanol, 2-butanol, 2-hexanol, cyclohexanol, and tert-butanol.
  • the method for preparing a fast-absorbing and flattening dry biological heart valve wherein an animal pericardium is sequentially immersed in 25% ethanol / 25% isopropanol / 50% glycerol at 25-45 ° C in a range of 20- 30h, 45% ethanol / 45% isopropanol / 10% glycerol for 20-30 hours, complete gradient dehydration and drying.
  • the method for preparing a fast-absorbing and flattening dry biological heart valve wherein before the animal pericardium is cross-linked with a glutaraldehyde aqueous solution, the method further includes decellularizing the animal pericardium.
  • the method for preparing a fast-absorbing and flattening dry biological heart valve wherein, before the animal pericardium is cross-linked with an aqueous solution of glutaraldehyde, the fresh animal pericardium is heated at 3 to 5 ° C and 80 to 80 ° C. Rinse with distilled water at 120RPM for 1.5 ⁇ 3h under shaking conditions.
  • the present invention also provides a dry biological heart valve that can quickly absorb and flatten, and is prepared by using the preparation method described in any one of the above.
  • the present invention provides a dry biological heart valve that can absorb water quickly and flatten, and a preparation method thereof.
  • the dry biological heart valve prepared by using the preparation method of the invention has good performance of rapid water absorption and self-healing. Can quickly absorb water and flatten under pressure test.
  • the present invention provides a dry biological heart valve that can quickly absorb and flatten, and a method for preparing the same.
  • a dry biological heart valve that can quickly absorb and flatten
  • a method for preparing the same In order to make the purpose, technical solution, and effect of the present invention clearer and clearer, the present invention is described in further detail below. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.
  • a method for preparing a dry biological heart valve capable of quickly absorbing and flattening provided by a preferred embodiment of the present invention, that is, an improved method for quickly absorbing and recovering water from a pre-installed dry biological heart valve, which includes the steps of:
  • the animal pericardium is cross-linked with an aqueous glutaraldehyde solution, then immersed in an extracellular matrix bioenzyme aqueous solution, and finally dried to obtain a dry biological heart valve that can absorb and flatten quickly.
  • the drying means dehydration drying in an alcohol solvent.
  • the present invention focuses on improving the fast water-absorbing and self-healing performance of a dry biological valve.
  • the present invention creatively adds biological enzymes to the pericardium of an animal glutaraldehyde cross-linked treatment, so as to make artificial biological valve tissue The effect of rapid water repelling, so as to obtain a pre-installed dry biological heart valve with fast water absorption and self-healing performance.
  • the preparation method of the present invention includes: 1. cross-linking of a biological valve; 2. water absorption improvement of the biological valve to improve biochemical treatment; 3. dehydration and drying of a gradient concentration of an alcohol solvent.
  • the water absorption improvement of the biovalve to improve the biochemical treatment and the dehydration and drying of the gradient concentration alcohol solvent are the key steps of the present invention.
  • the animal pericardium according to the present invention includes, but is not limited to, a pig pericardial valve, a bovine pericardial valve, and the like.
  • the method before the animal pericardium is cross-linked with an aqueous solution of glutaraldehyde, the method further includes the steps of decellularizing the animal pericardium and cleaning the animal pericardium.
  • fresh pericardial tissues of pigs or cattle were collected and stored under low temperature and humid conditions at 4 ° C. The pericardial tissue was washed with distilled water under gentle vibration and fluid pressure under oscillating conditions to remove adhered non-pericardial and non-collagenous tissue.
  • the washing according to the present invention achieves effective decellularization of the pericardial tissue through osmotic shock, and preferably the washing is continued until there is no visible adhesion of non-pericardial or non-collagenous tissue.
  • the step of cleaning the animal pericardium cleanly comprises: washing the fresh animal pericardium with distilled water at a temperature of 3 to 5 ° C. and a rotation speed of 80 to 120 RPM for 1.5 to 3 hours.
  • the pericardium of fresh animal pig or cow
  • the volume concentration of the glutaraldehyde aqueous solution is preferably 0.1 to 5%, for example, it can be 0.1%, 1%, 5%, etc.
  • the pH of the glutaraldehyde aqueous solution is preferably 7 to 8 , For example, 7, 7.4, 8 and so on.
  • the animal pericardium is cross-linked with an aqueous solution of glutaraldehyde under shaking conditions at 20 to 45 ° C. for 1 to 7 days. This step is the cross-linking of the biological valve, which will achieve the stable cross-linking of most collagen tissues, improve the structural stability of the entire pericardial tissue, and reduce or even eliminate immunogenicity.
  • the extracellular matrix biological enzyme aqueous solution is one or more mixed solutions of collagenase, elastase, hyaluronidase, and chondroitin sulfate.
  • concentration of the extracellular matrix biological enzyme aqueous solution is preferably 0.1 to 50 U / ml, and may be, for example, 0.1 U / ml, 1 U / ml, 20 U / ml, 50 U / ml, or the like.
  • the animal pericardium after the cross-linking treatment is immersed in an extracellular matrix bioenzyme aqueous solution under shaking conditions at 25 to 37 ° C. for 12 to 72 hours. This step is to improve the biochemical treatment of the water absorption of the biological valve, and it is necessary to ensure that the extracellular matrix bioenzyme reaches a near-saturated physical penetration, so as to introduce as much extracellular matrix bioenzyme as possible.
  • the dehydration and drying in an alcohol solvent according to the present invention is preferably a dehydration and drying with a gradient concentration alcohol mixed solvent.
  • the alcohol solvents include, but are not limited to, methanol, ethanol, n-propanol, isopropanol, glycerol, n-butanol, n-pentanol, n-undecanol, n-dodecanol, 2-propanol, One or more of 2-butanol, 2-hexanol, cyclohexanol, tert-butanol, and the like are mixed.
  • the animal pericardium is immersed in order of 25% ethanol / 25% isopropanol / 50% glycerol at 25 to 45 ° C for 20 to 30 hours (for example, 24 hours), 45% ethanol / 45% Isopropanol / 10% glycerol for 20 to 30 hours (for example, 24 hours), to complete the gradient dehydration and drying of the animal pericardium.
  • the embodiment of the present invention also provides a dry biological heart valve that can quickly absorb and flatten, and is prepared by using the preparation method described in any one of the above.
  • the dried biological heart valve prepared by using the preparation method of the present invention has good fast water absorption and self-healing performance, and can quickly absorb water and flatten under the simulated folding test.
  • the invention adopts a unique pre-installed dry biological heart valve to quickly absorb water and self-recovery and improve technology, so that the prepared dry biological heart valve has good water-absorbing and self-healing performance after being implanted into a human body, and can quickly absorb water and flatten under a simulated folding test.
  • Pre-packed dry biovalves stored without glutaraldehyde solution. It can reduce the residue of glutaraldehyde, reduce the calcification problem and toxicity caused by glutaraldehyde, simplify the preoperative installation of the valve system, and reduce the additional risk of surgery.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Collagenase is from Sigma-Aldrich.
  • the cleaned pig pericardium was crosslinked in a 1% volume concentration glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48h. Wash with distilled water. Then, it was immersed in a 10 U / ml aqueous collagenase solution at 37 ° C for 24 hours.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Elastase is from Shanghai Aladdin Biochemical Technology Co., Ltd.
  • the cleaned pig pericardium was crosslinked in a 1% volume concentration glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48h. Wash with distilled water. Then immerse it in a 5U / ml elastase aqueous solution at 37 ° C for 24h.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Elastase and hyaluronidase are from Shanghai Aladdin Biochemical Technology Co., Ltd.
  • the cleaned pig pericardium was cross-linked in a 1% volume glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48 hours. Wash with distilled water. Then immerse it in a mixed solution of 1U / ml elastase and 5U / ml hyaluronidase at 37 ° C for 24h.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Elastase and hyaluronidase are from Shanghai Aladdin Biochemical Technology Co., Ltd.
  • the cleaned pig pericardium was crosslinked in a 1% volume concentration glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48h. Wash with distilled water. Then, it was immersed in a 50U / ml chondroitin sulfate mixed aqueous solution at 37 ° C for 24 hours.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Elastase and hyaluronidase are from Shanghai Aladdin Biochemical Technology Co., Ltd.
  • the cleaned pig pericardium was crosslinked in a 1% volume concentration glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48h. Wash with distilled water. Then immerse in a 50U / ml collagenase and chondroitin sulfate aqueous solution at 37 ° C for 24h.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • Fresh pig pericardium comes from the local slaughterhouse.
  • Glutaraldehyde is from Chengdu Best Reagent Company.
  • Elastase and hyaluronidase are from Shanghai Aladdin Biochemical Technology Co., Ltd.
  • the cleaned pig pericardium was crosslinked in a 1% volume concentration glutaraldehyde aqueous solution (pH 7.4, 25 ° C) for 48h. Wash with distilled water. Then immerse in a mixed aqueous solution of collagenase and chondroitin sulfate at 0.1 U / ml for 24 hours at 37 ° C.
  • the dried biological heart valve prepared in this embodiment can quickly flatten out within 3 minutes of immersion in water under simulated bending test conditions (10kg weight folding after two folds) without obvious folding damage. Under the uniaxial tensile test (1 * 5cm sample size), the tensile breaking stress is greater than 15N.
  • the present invention provides a dry biological heart valve that can absorb water quickly and flatten, and a preparation method thereof.
  • the dry biological heart valve prepared by using the preparation method of the present invention has good rapid water absorption and self-healing properties. It can quickly absorb water and flatten under the simulated folding test.
  • the pre-installed dry biological valve stored without glutaraldehyde solution can reduce the residual glutaraldehyde, reduce the calcification problem and toxicity caused by glutaraldehyde, simplify the preoperative installation of the valve system, and reduce the additional risk of surgery.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une valve cardiaque biologique sèche capable d'absorber rapidement l'eau et de s'aplatir, et son procédé de préparation. Le procédé de préparation comprend les étapes suivantes consistant à : effectuer un traitement de réticulation sur un péricarde animal à l'aide d'une solution aqueuse de glutaraldéhyde, puis immerger le péricarde animal dans une solution aqueuse d'enzyme biologique à matrice extracellulaire, et enfin, sécher le péricarde animal pour obtenir une valve cardiaque biologique sèche capable d'absorber rapidement l'eau et de s'aplatir. La valve cardiaque biologique sèche préparée présente une bonne performance en termes d'auto-aplatissement et d'absorption d'eau rapide, et est capable d'absorber rapidement de l'eau et de s'aplatir sous un test de pliage et de pression simulé.
PCT/CN2019/105361 2018-09-19 2019-09-11 Valve cardiaque biologique sèche capable d'absorber rapidement de l'eau et de s'aplatir, et son procédé de préparation WO2020057414A1 (fr)

Applications Claiming Priority (2)

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CN201811095786.4 2018-09-19
CN201811095786.4A CN109172866A (zh) 2018-09-19 2018-09-19 一种可快速吸水展平的干燥生物心脏瓣膜及其制备方法

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CN109172866A (zh) * 2018-09-19 2019-01-11 杭州启明医疗器械有限公司 一种可快速吸水展平的干燥生物心脏瓣膜及其制备方法
CN110101912B (zh) * 2019-05-16 2020-03-10 四川大学 一种含促进内皮化多肽的干燥人工生物心脏瓣膜及其制备方法
CN110101911B (zh) * 2019-05-16 2020-03-10 四川大学 一种含促进内皮化生长因子的干燥人工生物心脏瓣膜及其制备方法
CN110613865A (zh) * 2019-11-07 2019-12-27 四川大学 碳二亚胺和多酚组合处理的生物瓣膜材料制备及保存方法
US12083009B2 (en) * 2020-04-15 2024-09-10 Vitae LLC Method of processing collagen-based tissue for bioprosthetic devices
CN111567514A (zh) * 2020-04-20 2020-08-25 上海以心医疗器械有限公司 一种保存新鲜生物组织的方法

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