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WO2022121912A1 - Procédé de réticulation de biovalve pour améliorer des propriétés mécaniques et d'anticoagulation, matériau de biovalve et application correspondante - Google Patents

Procédé de réticulation de biovalve pour améliorer des propriétés mécaniques et d'anticoagulation, matériau de biovalve et application correspondante Download PDF

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Publication number
WO2022121912A1
WO2022121912A1 PCT/CN2021/136200 CN2021136200W WO2022121912A1 WO 2022121912 A1 WO2022121912 A1 WO 2022121912A1 CN 2021136200 W CN2021136200 W CN 2021136200W WO 2022121912 A1 WO2022121912 A1 WO 2022121912A1
Authority
WO
WIPO (PCT)
Prior art keywords
biological
valve
cross
linking
dihydroxybenzaldehyde
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.)
Ceased
Application number
PCT/CN2021/136200
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English (en)
Chinese (zh)
Inventor
王云兵
郑城
吴柄钢
雷洋
杨立
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jilin Venus Haoyue Medical Ltd
Original Assignee
Jilin Venus Haoyue Medical Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Jilin Venus Haoyue Medical Ltd filed Critical Jilin Venus Haoyue Medical Ltd
Publication of WO2022121912A1 publication Critical patent/WO2022121912A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • 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 belongs to the technical field of biomedical materials, and in particular relates to a biological valve cross-linking method for improving mechanical and anticoagulant properties, a biological valve material and applications thereof.
  • the artificial heart valves widely used in clinic include mechanical valve and biological valve.
  • the hemocompatibility and hemodynamic properties of artificial bioprosthetic valves are better than those of mechanical valves, and lifelong anticoagulation therapy is not required.
  • the service life of the biological valve is about 10-15 years. After the valve fails, it must be replaced by a second operation through thoracotomy or intervention.
  • the interventional biological heart valve the blood flow in the heart is fast, and the blood compatibility of the biological valve is relatively good, so the probability of thrombosis is small, and the interventional biological valve generally does not require long-term use of anticoagulant drugs.
  • glutaraldehyde cross-linking is a key step in the preparation process of existing biological valve products on the market.
  • the mechanical strength of the existing glutaraldehyde cross-linked pericardium still needs to be further improved, especially compared with long-term service.
  • the valve leaflet material needs to use thicker pericardium raw materials to meet the requirements of mechanical properties, and the utilization rate of raw materials is low, which leads to its high cost.
  • the biological valve cross-linking method specifically includes the following steps:
  • step S5 carrying out oxidative cross-linking induced by ammonium persulfate on the biological material processed in step S4;
  • the biological material can be a biological valve material commonly used in the prior art, and can be selected from pericardium, heart valve, intestinal mucosa, meninges, lung membrane, blood vessel, skin or ligament, preferably porcine or bovine pericardium.
  • step S1 collecting fresh biological material, it needs to be stored in a low temperature and humid state of 4 degrees Celsius.
  • step S3 the 3,4-dihydroxybenzaldehyde is pre-dissolved in a 25vt% ethanol solution to prepare a 3,4-dihydroxybenzaldehyde solution with a mass concentration of 1-20%.
  • This step is required to ensure that the 3,4-dihydroxybenzaldehyde reaches a near-saturated chemical binding, thereby introducing as much 3,4-dihydroxybenzaldehyde as possible.
  • the ethanol solutions mentioned above are all aqueous ethanol solutions.
  • the diphenol group is chemically linked to the biological valve material through a carbon-nitrogen double bond.
  • the invention improves the cross-linking process of the biological valve material through 3,4-dihydroxybenzaldehyde, can improve the breaking tensile strength, anti-platelet adhesion and anti-coagulation properties of the biological valve material, and potentially enhances its biocompatibility and use. life.
  • Figure 2 is a schematic diagram of the Cauchy stress-fracture tensile strength results of biomaterials.
  • this experiment is a scanning electron microscope detection of blood contacting the surface of the test material in the rabbit half body.
  • the control group was the glutaraldehyde cross-linking treatment group
  • the experimental group was the 3,4-dihydroxybenzaldehyde cross-linking treatment group.
  • the blood cells adhered to the surface of the material in the experimental group after being contacted with blood decreased, and the fibrin network formed at the same time decreased.
  • Scale bar shown is 50 ⁇ m.

Landscapes

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

Abstract

L'invention concerne un procédé de réticulation de biovalve pour améliorer des propriétés mécaniques et d'anticoagulation, un matériau de biovalve et une application correspondante, se rapportant au domaine technique des matériaux biomédicaux. Dans le procédé de réticulation de biovalve, un biomatériau est modifié à l'aide de 3,4-dihydroxybenzaldéhyde et des groupes diphénol sont introduits dans le biomatériau et ensuite polymérisés et réticulés les uns avec les autres, ce qui permet d'obtenir une immobilisation par réticulation de la biovalve. Par rapport à la réticulation par glutaraldéhyde classique, le procédé peut améliorer la résistance à la traction à la rupture, l'adhérence des anti-plaquettes et les performances d'anticoagulation du biomatériau, peut potentiellement améliorer la biocompatibilité du biomatériau et prolonger la durée de vie du biomatériau.
PCT/CN2021/136200 2020-12-08 2021-12-07 Procédé de réticulation de biovalve pour améliorer des propriétés mécaniques et d'anticoagulation, matériau de biovalve et application correspondante Ceased WO2022121912A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202011421499.5A CN112472871B (zh) 2020-12-08 2020-12-08 一种提高力学及抗凝血性能的生物瓣膜交联方法
CN202011421499.5 2020-12-08

Publications (1)

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WO2022121912A1 true WO2022121912A1 (fr) 2022-06-16

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CN (1) CN112472871B (fr)
WO (1) WO2022121912A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
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WO2024027195A1 (fr) * 2022-08-04 2024-02-08 吉林启明皓月生物科技有限公司 Procédé de traitement de matériau de biofilm, matériau de biofilm et biovalve artificielle

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CN112472871B (zh) * 2020-12-08 2022-05-24 吉林启明皓月生物科技有限公司 一种提高力学及抗凝血性能的生物瓣膜交联方法
CN114748696B (zh) * 2021-11-17 2022-12-23 四川大学 一种共交联后双键交联生物瓣膜材料及其制备方法和应用
CN113952513B (zh) * 2021-11-29 2022-11-15 四川大学华西医院 一种抗衰败人工生物瓣膜及其制备方法和应用

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WO2002060505A2 (fr) * 2001-01-31 2002-08-08 Medtronic, Inc. Procede de revetement pour surfaces de dispositifs medicaux
CN108159482A (zh) * 2018-01-02 2018-06-15 上海其胜生物制剂有限公司 一种具有温敏特性和高组织粘附力的可注射天然水凝胶体系及其制备方法
CN108498869A (zh) * 2018-04-08 2018-09-07 中国医学科学院生物医学工程研究所 多酚类交联剂及其在制备抗钙化生物瓣膜中的应用
CN110585486A (zh) * 2019-08-28 2019-12-20 湖南光琇医院有限公司 羊膜复合材料及其制备方法和应用
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CN111569152A (zh) * 2020-05-28 2020-08-25 四川大学 一种兼具抗凝血和抗钙化性能的生物瓣膜及其制备方法
CN112472871A (zh) * 2020-12-08 2021-03-12 四川大学 一种提高力学及抗凝血性能的生物瓣膜交联方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024027195A1 (fr) * 2022-08-04 2024-02-08 吉林启明皓月生物科技有限公司 Procédé de traitement de matériau de biofilm, matériau de biofilm et biovalve artificielle

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CN112472871A (zh) 2021-03-12

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