铁基材料在生物可降解血管支架领域的研究进展

许雅南; 王伟强; 杨帅康; 王轶农

doi:10.7513/j.issn.1004-7638.2023.04.023

铁基材料在生物可降解血管支架领域的研究进展

doi: 10.7513/j.issn.1004-7638.2023.04.023

大连理工大学材料科学与工程学院, 辽宁大连116024

基金项目: 国家重点研究发展计划（2019YFA0705300）；中央高校基础研究基金（DUT22YG118，LD202219）。

详细信息

作者简介:
许雅南，1996年出生，女，内蒙古赤峰人，博士研究生，主要研究方向为医用金属材料，E-mail：yananxu@mail.dlut.edu.cn

通讯作者:
王伟强，1974年出生，男，博士，辽宁大连人，副教授，主要研究方向为医用金属材料，E-mail：wangwq@dlut.edu.cn

中图分类号: TG174,TB34
计量
- 文章访问数: 922
- HTML全文浏览量: 157
- PDF下载量: 71
- 被引次数: 0
出版历程
- 收稿日期: 2023-02-20
- 刊出日期: 2023-08-30

Research progress of biodegradable iron-based materials for vascular stents

School of Materials Science and Engineering , Dalian University of Technology, Dalian 116024, Liaoning, China

摘要

摘要: 铁基可降解金属材料是最有潜力替代永久性血管支架的材料之一，降解速率慢是制约其发展的主要原因。对可降解铁基血管支架材料近年来的研究进行了梳理、总结和展望，发现众多研究者通过调整其微观组织结构、表面处理、合金化、和“复合”材料设计等方式对其生物相容性、腐蚀降解行为、机械性能和磁性能等方面进行了优化，以期设计理想铁基可降解血管支架材料。然而，单一的微观组织结构调整，虽然保证了纯铁的生物相容性，但对降解性能的提升有限；通过特殊的表面处理技术，也可以提高纯铁近表区域的腐蚀速率，但是难以优化基体的腐蚀性能；合金化可以均匀地提高材料的综合性能，但是单一合金化的方式所制备的合金和理想血管支架的性能要求仍然有差距。认为在合金化的基础上进行“复合”材料设计，可以更好地优化材料的综合性能。
- 铁基合金 /
- 血管支架 /
- 降解性能 /
- 生物相容性
Abstract: Iron-based biodegradable metal material is one of the most potential materials to replace permanent vascular stents. The slow degradation rate is the main problem hindering its development. Many researchers optimized its biocompatibility, corrosion and degradation behaviors, mechanical properties and magnetic properties by adjusting its microstructure, surface treatment, alloying, and "composite" material design, aiming for the ideal iron-based biodegradable stent materials. Although the pure iron compatibility can be ensured by microstructure adjustment, its degradability improvement is limited. While, it is hard to optimize the corrosion resistance properties of pure iron matrix, despite the fact that the corrosion rate of the close-to-surface regions can be enhanced by specific surface treatments. Among these ways, the comprehensive properties of materials were optimized via "composite" materials designed by alloying. However, a great improvement is still required for the alloying materials to satisfy the properties of ideal stents. This work summarized the researches of iron-based biodegradable stent materials from the above aspects and suggestions on the future research directions were also proposed.
- iron-based alloys /
- vascular stent /
- degradation properties /
- biocompatibility

HTML全文

图 1 理想可降解血管支架治疗过程

(a)血管病变狭窄后植入支架；(b)血管重塑；(c)支架在体内均匀降解；(d）支架完全在体内消失

Figure 1. Ideal biodegradable vascular stent treatment process

下载: 全尺寸图片幻灯片

图 2 "复合" 材料设计示意

Figure 2. Schematic diagram of "composite" material design

下载: 全尺寸图片幻灯片

参考文献(49)

[1]	Ma Liyuan, Wang Zengwu, Fan Jing, et al. Summary of《China cardiovascular health and disease report 2021》[J]. Chinese Journal of Interventional Cardiology, 2022,30(7):487−496. (马丽媛, 王增武, 樊静, 等. 中国心血管健康与疾病报告2021概要[J]. 中国介入心脏病学杂志, 2022,30(7):487−496. Ma Liyuan, Wang Zengwu, Fan Jing, et al. Summary of《China cardiovascular health and disease report 2021》[J]. Chinese Journal of Interventional Cardiology, 2022, 30(7): 487-496
[2]	Daemen J, Boersma E, Flather M, et al. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials[J]. Circulation, 2008,118(11):1146−1154. doi: 10.1161/circulationaha.107.752147
[3]	Serruys P W, Jaegere P D, Kiemeneij F, et al. A Comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease[J]. New England Journal of Medicine, 1994, 331: 489 - 495.
[4]	Onuma Y, Serruys P W. Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization[J]. Circulation, 2011,123(7):779−797. doi: 10.1161/CIRCULATIONAHA.110.971606
[5]	Zheng Y F, Gu X N, Witte F. Biodegradable metals[J]. Materials Science and Engineering, 2014,77:1−34. doi: 10.1016/j.mser.2014.01.001
[6]	Loffredo S, Hermawan H, Vedani M, et al. 20 - Absorbable metals for cardiovascular applications[M]. Niinomi M, ed. Metals for Biomedical Devices (Second Edition). Woodhead Publishing, 2019: 523-543.
[7]	Liu Y, Zheng Y F, Chen X H, et al. Fundamental theory of biodegradable metals—definition, criteria, and design[J]. Advanced Functional Materials, 2019,29(18):1805402. doi: 10.1002/adfm.201805402
[8]	Chen Q Z, Thouas G A. Metallic implant biomaterials[J]. Materials Science and Engineering, 2015,87:1−57. doi: 10.1016/j.mser.2014.10.001
[9]	Underwood E J. Trace elements in human and animal nutrition[J]. Soil Science, 1963, 95(4): 287.
[10]	Schinhammer M, Hanzi A C, Loffler J F, et al. Design strategy for biodegradable Fe-based alloys for medical applications[J]. Acta Biomaterialia, 2010,6(5):1705−1713. doi: 10.1016/j.actbio.2009.07.039
[11]	Peuster M, Wohlsein P, Brügmann M, et al. A novel approach to temporary stenting: Degradable cardiovascular stents produced from corrodible metal - Results 6-18 months after implantation into New Zealand white rabbits[J]. Heart, 2001,86(5):563−569. doi: 10.1136/heart.86.5.563
[12]	Peuster M, Hesse C, Schloo T, et al. Long-term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta[J]. Biomaterials, 2006,27(28):4955−4962. doi: 10.1016/j.biomaterials.2006.05.029
[13]	Ron W, Rajbabu P, Richard B, et al. Short-term effects of biocorrodible iron stents in porcine coronary arteries[J]. Journal of Interventional Cardiology, 2008,21(1):15−20. doi: 10.1111/j.1540-8183.2007.00319.x
[14]	Obayi C S, Tolouei R, Mostavan A, et al. Effect of grain sizes on mechanical properties and biodegradation behavior of pure iron for cardiovascular stent application[J]. Biomatter, 2016,6(1):959874. doi: 10.4161/21592527.2014.959874
[15]	Moravej M, Purnama A, Fiset M, et al. Electroformed pure iron as a new biomaterial for degradable stents: In vitro degradation and preliminary cell viability studies[J]. Acta Biomaterialia, 2010,6(5):1843−1851. doi: 10.1016/j.actbio.2010.01.008
[16]	Qi Y, Li X, He Y, et al. Mechanism of acceleration of iron corrosion by a polylactide coating[J]. ACS Applied Materials & Interfaces, 2019,11(1):202−218. doi: 10.1021/acsami.8b17125
[17]	Gorejova R, Orinakova R, Macko J, et al. Electrochemical behavior, biocompatibility and mechanical performance of biodegradable iron with PEI coating[J]. Journal of Biomedical Materals Research Part A, 2022,110(3):659−671. doi: 10.1002/jbm.a.37318
[18]	Cheng J, Huang T, Zheng Y F. Relatively uniform and accelerated degradation of pure iron coated with micro-patterned Au disc arrays[J]. Materials Science and Engineering:C, 2015,48:679−687. doi: 10.1016/j.msec.2014.12.053
[19]	Huang T, Zheng Y. Uniform and accelerated degradation of pure iron patterned by Pt disc arrays[J]. Scientific Reports, 2016,6:23627. doi: 10.1038/srep23627
[20]	Zhou J C, Yang Y Y, Alonso Frank M, et al. Accelerated degradation behavior and cytocompatibility of pure iron treated with sandblasting[J]. ACS Applied Materials & Interfaces, 2016,8(40):26482−26492. doi: 10.1021/acsami.6b07068
[21]	Bagherifard S, Molla M F, Kajanek D, et al. Accelerated biodegradation and improved mechanical performance of pure iron through surface grain refinement[J]. Acta Biomaterialia, 2019,98:88−102. doi: 10.1016/j.actbio.2019.05.033
[22]	Wang H N, Zheng Y, Li Y, et al. Improvement of in vitro corrosion and cytocompatibility of biodegradable Fe surface modified by Zn ion implantation[J]. Applied Surface Science, 2017,403:168−176. doi: 10.1016/j.apsusc.2017.01.158
[23]	Chen H Y, Zhang E L, Yang K. Microstructure, corrosion properties and bio-compatibility of calcium zinc phosphate coating on pure iron for biomedical application[J]. Materials Science and Engineering:C, 2014,34:201−206. doi: 10.1016/j.msec.2013.09.010
[24]	Zhu S, Huang N, Shu H, et al. Corrosion resistance and blood compatibility of lanthanum ion implanted pure iron by MEVVA[J]. Applied Surface Science, 2009,256(1):99−104. doi: 10.1016/j.apsusc.2009.07.082
[25]	Zhu S F, Huang N, Xu L, et al. Biocompatibility of Fe–O films synthesized by plasma immersion ion implantation and deposition[J]. Surface and Coatings Technology, 2009,203(10):1523−1529. doi: 10.1016/j.surfcoat.2008.11.033
[26]	Hermawan H, Dubé M D. Development of degradable Fe-35Mn alloy for biomedical application[J]. Advanced Materials Research, 2006,15-17:107−112. doi: 10.4028/www.scientific.net/AMR.15-17.107
[27]	Hermawan H, Purnama A, Dube D, et al. Fe-Mn alloys for metallic biodegradable stents: degradation and cell viability studies[J]. Acta Biomaterialia, 2010,6(5):1852−1860. doi: 10.1016/j.actbio.2009.11.025
[28]	Capek J, Kubasek J, Vojtech D, et al. Microstructural, mechanical, corrosion and cytotoxicity characterization of the hot forged FeMn30(%) alloy[J]. Materials Science and Engineering:C, 2016,58:900−908. doi: 10.1016/j.msec.2015.09.049
[29]	Traverson M, Heiden M, Stanciu L A, et al. In Vivo evaluation of biodegradability and biocompatibility of Fe30Mn alloy[J]. Veterinary and Comparative Orthopaedics and Traumatology, 2018,31(1):10−16. doi: 10.3415/VCOT-17-06-0080
[30]	Sotoudehbagha P, Sheibani S, Khakbiz M, et al. Novel antibacterial biodegradable Fe-Mn-Ag alloys produced by mechanical alloying[J]. Materials Science and Engineering:C, 2018,88:88−94. doi: 10.1016/j.msec.2018.03.005
[31]	Niendorf T, Brenne F, Hoyer P, et al. Processing of new materials by additive manufacturing: Iron-based alloys containing silver for biomedical applications[J]. Metallurgical and Materials Transactions A, 2015,46(7):2829−2833. doi: 10.1007/s11661-015-2932-2
[32]	Hong D, Chou D T, Velikokhatnyi O I, et al. Binder-jetting 3D printing and alloy development of new biodegradable Fe-Mn-Ca/Mg alloys[J]. Acta Biomaterialia, 2016,45:375−386. doi: 10.1016/j.actbio.2016.08.032
[33]	Xu W, Lu X, Tan L, et al. Study on properties of a novel biodegradable Fe-30Mn-1C alloy[J]. Acta Metallurgica Sinica, 2011,47(10):1342−1347. doi: 10.3724/SP.J.1037.2011.00258
[34]	Harjanto S, Pratesa Y, Suharno B, et al. Corrosion behavior of Fe-Mn-C alloy as degradable materials candidate fabricated via powder metallurgy process[J]. Advanced Materials Research, 2012: 386-389.
[35]	Liu B, Zheng Y F, Ruan L Q. In vitro investigation of Fe30Mn6Si shape memory alloy as potential biodegradable metallic material[J]. Materials Letters, 2011,65(3):540−543. doi: 10.1016/j.matlet.2010.10.068
[36]	Drevet R, Zhukova Y, Kadirov P, et al. Tunable corrosion behavior of calcium phosphate coated Fe-Mn-Si alloys for bone implant applications[J]. Metallurgical and Materials Transactions A, 2018,49(12):6553−6560. doi: 10.1007/s11661-018-4907-6
[37]	Hufenbach J, Wendrock H, Kochta F, et al. Novel biodegradable Fe-Mn-C-S alloy with superior mechanical and corrosion properties[J]. Materials Letters, 2017,186:330−333. doi: 10.1016/j.matlet.2016.10.037
[38]	Hufenbach J, Kochta F, Wendrock H, et al. S and B microalloying of biodegradable Fe-30Mn-1C - effects on microstructure, tensile properties, in vitro degradation and cytotoxicity[J]. Materials & Design, 2018,142:22−35. doi: 10.1016/j.matdes.2018.01.005
[39]	Venezuela J, Dargusch M S. Addressing the slow corrosion rate of biodegradable Fe-Mn: Current approaches and future trends[J]. Current Opinion in Solid State and Materials Science, 2020,24(3):100822. doi: 10.1016/j.cossms.2020.100822
[40]	Lin W, Zhang G, Cao P, et al. Cytotoxicity and its test methodology for a bioabsorbable nitrided iron stent[J]. Journal of Biomedical Materials Researcheh, 2015,103(4):764−776. doi: 10.1002/jbm.b.33246
[41]	Lin W, Qin L, Qi H, et al. Long-term in vivo corrosion behavior, biocompatibility and bioresorption mechanism of a bioresorbable nitrided iron scaffold[J]. Acta Biomaterialia, 2017,54:454−468. doi: 10.1016/j.actbio.2017.03.020
[42]	Wang H, Zheng Y, Liu J, et al. In vitro corrosion properties and cytocompatibility of Fe-Ga alloys as potential biodegradable metallic materials[J]. Materials Science and Engineering:C, 2017,71:60−66. doi: 10.1016/j.msec.2016.09.086
[43]	Capek J, Msallamova S, Jablonska E, et al. A novel high-strength and highly corrosive biodegradable Fe-Pd alloy: Structural, mechanical and in vitro corrosion and cytotoxicity study[J]. Materials Science and Engineering:C, 2017,79:550−562. doi: 10.1016/j.msec.2017.05.100
[44]	Mostavan A, Paternoster C, Tolouei R, et al. Effect of electrolyte composition and deposition current for Fe/Fe-P electroformed bilayers for biodegradable metallic medical applications[J]. Materials Science and Engineering:C, 2017,70(1):195−206. doi: 10.1016/j.msec.2016.08.026
[45]	Liu B, Zheng Y F. Effects of alloying elements (Mn, Co, Al, W, Sn, B, C and S) on biodegradability and in vitro biocompatibility of pure iron[J]. Acta Biomaterialia, 2011,7(3):1407−1420. doi: 10.1016/j.actbio.2010.11.001
[46]	Xu Y N, Wang W Q, Yu F, et al. Effects of pulse frequency and current density on microstructure and properties of biodegradable Fe-Zn alloy[J]. Journal of Materials Research and Technology, 2022,18:44−58. doi: 10.1016/j.jmrt.2022.02.096
[47]	Xu Y N, Wang W Q, Yu F Y, et al. The enhancement of mechanical properties and uniform degradation of electrodeposited Fe-Zn alloys by multilayered design for biodegradable stent applications[J]. Acta Biomaterialia, 2023. https://doi.org/10.1016/j.actbio.2023.02.029.
[48]	Zheng J F, Xi Z W, Li Y, et al. Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery[J]. Bioactive Materials, 2022,17:496−505. doi: 10.1016/j.bioactmat.2022.01.005
[49]	Zheng J F, Qiu H, Tian Y, et al. Preclinical evaluation of a novel sirolimus-eluting iron bioresorbable coronary scaffold in porcine coronary artery at 6 months[J]. JACC:Cardiovascular Interventions, 2019,12(3):245−255. doi: 10.1016/j.jcin.2018.10.020