CN107648676A - 一种可降解铁基心血管支架材料及其制备方法 - Google Patents

一种可降解铁基心血管支架材料及其制备方法 Download PDF

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CN107648676A
CN107648676A CN201711089471.4A CN201711089471A CN107648676A CN 107648676 A CN107648676 A CN 107648676A CN 201711089471 A CN201711089471 A CN 201711089471A CN 107648676 A CN107648676 A CN 107648676A
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谭思暄
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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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by 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
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs

Abstract

本发明属于临床医学植入体技术领域，具体涉及一种可降解铁基心血管支架材料及其制备方法。本发明的技术方案如下：一种可降解铁基心血管支架材料，由铁粉、锰粉和银粉制备而成，铁粉、锰粉和银粉的质量比例为75:23:2，铁粉的纯度为99.99％，锰粉的纯度为99.99％，银粉的纯度为99.99％。本发明提供的支架材料具有优异力学性能、生物相容性、生物降解性及杀菌能力，完全满足临床医学介入疗法对植入体的要求。

Description

一种可降解铁基心血管支架材料及其制备方法
技术领域
本发明属于临床医学植入体技术领域，具体涉及一种可降解铁基心血管支架材料及其制备方法。
背景技术
随着社会的不断进步，心血管疾病的发病率逐渐增大，严重危害到人类的身体健康。目前心血管疾病通常采用介入疗法，由于血管支架的植入能够为心血管提供支撑，从而成为治疗心血管疾病最有效的方法之一。
临床上不仅希望可降解支架材料与生物体的良好适应性和生物相容性、无毒性，而且要求植入的支架能够在植入后最初的12个月内保持力学性能的完整性，并在之后的12-24个月内完全降解。传统的心血管支架材料一般采用可降解高分子、镁合金、铁基合金等。然而高分子材料不仅在降解过程中容易产生团聚现象，而且其X光显影效果差，不利于跟踪和定位，而镁合金的降解速率过快，不能保持所需的力学性能，因此均难以满足临床医学对可降解心血管支架材料的要求。铁基合金不仅具有优异的力学性能，而且是构成人体的必需微量元素之一，参与氧气的转运，铁离子还是很多酶促反应的辅助因子，直接影响DNA合成以及氧化还原酶的活性，因此铁基可降解材料作为可降解植入物时，其降解产生的铁离子可以被人体吸收参与新陈代谢，不会累积毒性，能够提供足够的安全保障，逐渐引起了临床医学的广泛关注。
发明内容
本发明提供一种可降解铁基心血管支架材料及其制备方法，该支架材料具有优异力学性能、生物相容性、生物降解性及杀菌能力，完全满足临床医学介入疗法对植入体的要求。
本发明的技术方案如下：
一种可降解铁基心血管支架材料，由铁粉、锰粉和银粉制备而成，铁粉、锰粉和银粉的质量比例为75:23:2，铁粉的纯度为99.99％，锰粉的纯度为99.99％，银粉的纯度为99.99％。
上述的可降解铁基心血管支架材料的制备方法，采用真空熔炼的方法，将所述铁粉、锰粉和银粉在15kg真空感应炉中于1600℃进行熔炼，在1100℃下保温2小时；将得到的合金锻造为20mm的圆棒，然后空冷，得到可降解铁基心血管支架材料。
本发明的有益效果为：通过在铁基合金中加入化学活性弱于铁的锰元素，能够加快铁在体液中的降解速率，同时锰可促进骨骼的生长发育，保护细胞中细粒体的完整，保持正常的脑功能，可改善肌体的造血功能，维持正常的糖代谢和脂肪代谢，可改善肌体的造血功能；而加入银元素使支架材料具有杀菌消炎的作用；所用铁粉、锰粉和银粉的质量比例为75:23:2，能够控制铁的降解速率，并符合人体心血管支架的降解速率要求；在1100℃下保温2小时，能使该合金形成纳米晶粒微观组织，增强其韧性；本发明所制备的可降解铁基心血管支架材料具有力学性能强、生物相容性好、生物降解能力合适、以及具有杀菌消炎的作用，符合医用植入材料的要求；在支架植入过程中以及后期的检查中，可以方便地通过X射线观察到心血管支架在体内的状况。
具体实施方式
一种可降解铁基心血管支架材料，由铁粉、锰粉和银粉制备而成，铁粉、锰粉和银粉的质量比例为75:23:2，铁粉的纯度为99.99％，锰粉的纯度为99.99％，银粉的纯度为99.99％。
上述的可降解铁基心血管支架材料的制备方法，采用真空熔炼的方法，将所述铁粉、锰粉和银粉在15kg真空感应炉中于1600℃进行熔炼，在1100℃下保温2小时；将得到的合金锻造为20mm的圆棒，然后空冷，得到可降解铁基心血管支架材料。
制得的可降解铁基心血管支架材料，其抗拉强度为1010MPa，断后延伸率为88％；在植入初期的12个月内具有完整的力学性能，在植入之后的16个月内完全降解，降解速度为1.02mm/年；其溶血率为2.45％，符合医用植入材料的要求。

Claims (2)

1.一种可降解铁基心血管支架材料，其特征在于，由铁粉、锰粉和银粉制备而成，铁粉、锰粉和银粉的质量比例为75:23:2，铁粉的纯度为99.99％，锰粉的纯度为99.99％，银粉的纯度为99.99％。
2.一种如权利要求1所述的可降解铁基心血管支架材料的制备方法，其特征在于，采用真空熔炼的方法，将所述铁粉、锰粉和银粉在15kg真空感应炉中于1600℃进行熔炼，在1100℃下保温2小时；将得到的合金锻造为20mm的圆棒，然后空冷，得到可降解铁基心血管支架材料。
CN201711089471.4A 2017-11-08 2017-11-08 一种可降解铁基心血管支架材料及其制备方法 Pending CN107648676A (zh)

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Application publication date: 20180202