Research Progress on Biocompatibility Evaluation of Biomedical Degradable Zinc Alloys
Received date: 2022-09-23
Revised date: 2022-10-25
Online published: 2023-01-09
Supported by
National Natural Science Foundation of China(51871020);National Key Research and Development Program of China(2016YFC1102500)
Zn and its alloys have recently been used as a new class of biodegradable biomedical metals besides magnesium and iron alloys, owing to their moderate corrosion rate and good mechanical properties. In recent years, researchers have rigorously studied the design, processing, and degradation mechanism of Zn alloys, but their biocompatibility has not been well explored. Past research on the biocompatibility of Zn alloys focused on in vitro cytotoxicity, hemolysis, and coagulation, and only a few materials were implanted into animals for characterizing the histocompatibility. Biocompatibility involves complex local and systemic reactions, such as cells, tissues, blood, and immunity. In addition to the physical and chemical properties of the material, the biocompatibility is also affected by interactions between the material and body. In this paper, the chemical and phase compositions of degradable zinc alloys were analyzed, and the biological evaluation methods were clarified. In view of the recent studies on zinc alloy biocompatibility, future research directions were proposed.
Key words： zinc alloy; biocompatibility; cytotoxicity; blood compatibility
Luning WANG , Yuxia YIN , Zhangzhi SHI , Qianqian HAN . Research Progress on Biocompatibility Evaluation of Biomedical Degradable Zinc Alloys[J]. Acta Metall Sin, 2023 , 59(3) : 319 -334 . DOI: 10.11900/0412.1961.2022.00471
| 1 | Scholten K, Meng E. Materials for microfabricated implantable devices: A review [J]. Lab Chip, 2015, 15: 4256 |
| 2 | Xiao M, Chen Y M, Biao M N, et al. Bio-functionalization of biomedical metals [J]. Mater. Sci. Eng., 2017, C70: 1057 |
| 3 | Pogorielov M, Husak E, Solodivnik A, et al. Magnesium-based biodegradable alloys: Degradation, application, and alloying elements [J]. Interv. Med. Appl. Sci., 2017, 9: 27 |
| 4 | Sharma M P. Corrosion of bio-materials [J]. J. Metall. Mater. Eng. Res., 2020, 10: 21 |
| 5 | Masiero G, Rodinò G, Matsuda J, et al. Bioresorbable coronary scaffold technologies: What's new? [J]. Cardiol. Clin., 2020, 38: 589 |
| 6 | Jinnouchi H, Torii S, Sakamoto A, et al. Fully bioresorbable vascular scaffolds: Lessons learned and future directions [J]. Nat. Rev. Cardiol., 2019, 16: 286 |
| 7 | Onuma Y, Muramatsu T, Kharlamov A, et al. Freeing the vessel from metallic cage: What can we achieve with bioresorbable vascular scaffolds? [J]. Cardiovasc. Interv. Ther., 2012, 27: 141 |
| 8 | de Pommereau A, de Hemptinne Q, Varenne O, et al. Bioresorbable vascular scaffolds: Time to absorb past lessons or fade away? Arch. Cardiovasc. Dis., 2018, 111: 229 |
| 9 | Liu J Y, Wang J G, Yu Y H, et al. Advances in biodegradable vascular stent materials [J]. Mater. Sci. Forum, 2020, 987: 93 |
| 10 | Zhu D H, Cockerill I, Su Y C, et al. Mechanical strength, biodegradation, and in vitro and in vivo biocompatibility of Zn biomaterials [J]. ACS Appl. Mater. Interfaces, 2019, 11: 6809 |
| 11 | G?sior G, Szczepański J, Radtke A. Biodegradable iron-based materials-what was done and what more can Be done? [J]. Materials, 2021, 14: 3381 |
| 12 | Zhou Y Z, Wu P, Yang Y W, et al. The microstructure, mechanical properties and degradation behavior of laser-melted Mg-Sn alloys [J]. J. Alloys Compd., 2016, 687: 109 |
| 13 | Wen P, Voshage M, Jauer L, et al. Laser additive manufacturing of Zn metal parts for biodegradable applications: Processing, formation quality and mechanical properties [J]. Mater. Des., 2018, 155: 36 |
| 14 | Song B, Dong S J, Liu Q, et al. Vacuum heat treatment of iron parts produced by selective laser melting: Microstructure, residual stress and tensile behavior [J]. Mater. Des., 2014, 54: 727 |
| 15 | Jo S, Whitmore L, Woo S, et al. Excellent age hardenability with the controllable microstructure of AXW100 magnesium sheet alloy [J]. Sci. Rep., 2020, 10: 22413 |
| 16 | Wang C R, Xi T F, Feng X M. The important rule of material and chemical characterization in device evaluation [J]. Chin. Med. Dev. Inf., 2007, 13(5): 4 |
| 16 | 王春仁, 奚廷斐, 冯晓明. 医疗器械生物材料表征和化学性能检测的重要性 [J]. 中国医疗器械信息, 2007, 13(5): 4 |
| 17 | Li H F, Wang P Y, Lin G C, et al. The role of rare earth elements in biodegradable metals: A review [J]. Acta Biomater., 2021, 129: 33 |
| 18 | Liu Y, Zheng Y F, Chen X H, et al. Fundamental theory of biodegradable metals—Definition, criteria, and design [J]. Adv. Funct. Mater., 2019, 29: 1805402 |
| 19 | Wang C, Yu Z T, Cui Y J, et al. Processing of a novel Zn alloy micro-tube for biodegradable vascular stent application [J]. J. Mater. Sci. Technol., 2016, 32: 925 |
| 20 | Zheng Y F, Xia D D, Chen Y N, et al. Additively manufactured biodegrabable metal implants [J]. Acta Metall. Sin., 2021, 57: 1499 |
| 20 | 郑玉峰, 夏丹丹, 谌雨农 等. 增材制造可降解金属医用植入物 [J]. 金属学报, 2021, 57: 1499 |
| 21 | Hernández-Escobar D, Champagne S, Yilmazer H, et al. Current status and perspectives of zinc-based absorbable alloys for biomedical applications [J]. Acta Biomater., 2019, 97: 1 |
| 22 | T?rne K, Larsson M, Norlin A, et al. Degradation of zinc in saline solutions, plasma, and whole blood [J]. J. Biomed. Mater. Res., 2016, 104B: 1141 |
| 23 | Su Y C, Cockerill I, Wang Y D, et al. Zinc-based biomaterials for regeneration and therapy [J]. Trends Biotechnol., 2019, 37: 428 |
| 24 | Hojyo S, Fukada T. Roles of zinc signaling in the immune system [J]. J. Immunol. Res., 2016, 2016: 6762343 |
| 25 | Berg J M, Shi Y G. The galvanization of biology: A growing appreciation for the roles of zinc [J]. Science, 1996, 271: 1081 |
| 26 | Yamaguchi M. Role of nutritional zinc in the prevention of osteoporosis [J]. Mol. Cell. Biochem., 2010, 338: 241 |
| 27 | Imbeault M, Helleboid P Y, Trono D. KRAB zinc-finger proteins contribute to the evolution of gene regulatory networks [J]. Nature, 2017, 543: 550 |
| 28 | Hennig B, Toborek M, McClain C J, et al. Nutritional implications in vascular endothelial cell metabolism [J]. J. Am. Coll. Nutr., 1996, 15: 345 |
| 29 | Yamaguchi M. Nutritional factors and bone homeostasis: Synergistic effect with zinc and genistein in osteogenesis [J]. Mol. Cell. Biochem., 2012, 366: 201 |
| 30 | Miller L V, Krebs N F, Hambidge K M. A mathematical model of zinc absorption in humans as a function of dietary zinc and phytate [J]. J. Nutr., 2007, 137: 135 |
| 31 | Bitanihirwe B K Y, Cunningham M G. Zinc: the brain's dark horse [J]. Synapse, 2010, 63: 1029 |
| 32 | Kabir H, Munir K, Wen C E, et al. Recent research and progress of biodegradable zinc alloys and composites for biomedical applications: Biomechanical and biocorrosion perspectives [J]. Bioact. Mater., 2021, 6: 836 |
| 33 | Yang N, Venezuela J, Almathami S, et al. Zinc-nutrient element based alloys for absorbable wound closure devices fabrication: Current status, challenges, and future prospects [J]. Biomaterials, 2022, 280: 121301 |
| 34 | Su Y C, Fu J Y, Lee W, et al. Improved mechanical, degradation, and biological performances of Zn-Fe alloys as bioresorbable implants [J]. Bioact. Mater., 2022, 17: 334 |
| 35 | Xia D D, Qin Y, Guo H, et al. Additively manufactured pure zinc porous scaffolds for critical-sized bone defects of rabbit femur [J]. Bioact. Mater., 2023, 19: 12 |
| 36 | ISO. Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process [S]. 2018 |
| 37 | Anderson J M. Biological responses to materials [J]. Annu. Rev. Mater. Res., 2001, 31: 81 |
| 38 | Williams D F. On the mechanisms of biocompatibility [J]. Biomaterials, 2008, 29: 2941 |
| 39 | Zhao P, Xing L N, Liu W B, et al. Biocompatibility evaluation of medical devices: Status, progress and trend [J]. China Med. Dev. Inf., 2021, 27(11): 1 |
| 39 | 赵 鹏, 邢丽娜, 刘文博 等. 医疗器械生物相容性评价: 现状、进展与趋势 [J]. 中国医疗器械信息, 2021, 27(11): 1 |
| 40 | Williams D F. On the nature of biomaterials [J]. Biomaterials, 2009, 30: 5897 |
| 41 | Geurtsen W. Biocompatibility of dental casting alloys [J]. Crit. Rev. Oral. Biol. Med., 2002, 13: 71 |
| 42 | Salimi A, Jamali Z, Atashbar S, et al. Pathogenic mechanisms and therapeutic implication in nickel-induced cell damage [J]. Endocr. Metab. Immune., 2020, 20: 968 |
| 43 | Hillen U, Haude M, Erbel R, et al. Evaluation of metal allergies in patients with coronary stents [J]. Contact Dermatitis, 2002, 47: 353 |
| 44 | Holton A D, Walsh E G, Brott B C, et al. Evaluation of in-stent stenosis by magnetic resonance phase-velocity mapping in nickel-titanium stents [J]. J. Magn. Reson. Imaging, 2005, 22: 248 |
| 45 | Liu P S, Yu B, Hu A M, et al. Development in applications of porous metals [J]. Trans. Nonferrous Met. Soc. China, 2001, 11: 629 |
| 46 | Qin J H, Chen Q, Yang C Y, et al. Research process on property and application of metal porous materials [J]. J. Alloys Compd., 2016, 654: 39 |
| 47 | Purdue P E, Koulouvaris P, Potter H G, et al. The cellular and molecular biology of periprosthetic osteolysis [J]. Clin. Orthop. Relat. Res., 2007, 454: 251 |
| 48 | Goodman S. Wear particulate and osteolysis [J]. Orthop. Clin. North Am., 2005, 36: 41 |
| 49 | Yang K, Shi J R, Wang L, et al. Bacterial anti-adhesion surface design: Surface patterning, roughness and wettability: A review [J]. J. Mater. Sci. Technol., 2022, 99: 82 |
| 50 | Yao X, Peng R, Ding J D. Cell-material interactions revealed via material techniques of surface patterning [J]. Adv. Mater., 2013, 25: 5257 |
| 51 | Brott T, Stump D. Overview of hemostasis and thrombosis [J]. Semin. Neurol., 1991, 11: 305 |
| 52 | Wehrmacher W H. Molecular markers of hemostasis: Introduction and overview [J]. Semin. Thromb. Hemost., 1984, 10: 215 |
| 53 | Wu S, Applewhite A J, Niezgoda J, et al. Oxidized regenerated cellulose/collagen dressings: Review of evidence and recommendations [J]. Adv. Skin Wound Care, 2017, 30: S1 |
| 54 | Zhang L, Wang S M, Tan M H, et al. Efficacy of oxidized regenerated cellulose/collagen dressing for management of skin wounds: A systematic review and meta-analysis [J]. Evid.-Based Complement. Alternat. Med., 2021, 2021: 1058671 |
| 55 | Liu C H, Wu S F, Hou L, et al. Study on cytotoxicity tests of medical devices based on IC50 [J]. Chin. J. Med. Lnstrument., 2014, 38: 433 |
| 55 | 刘成虎, 吴世福, 侯 丽 等. 基于IC50的医疗器械细胞毒性试验方法的研究 [J]. 中国医疗器械杂志, 2014, 38: 433 |
| 56 | Lin W J, Zhang G, Cao P, et al. Cytotoxicity and its test methodology for a bioabsorbable nitrided iron stent [J]. J. Biomed. Mater. Res., 2015, 103B: 764 |
| 57 | Dargusch M S, Balasubramani N, Venezuela J, et al. Improved biodegradable magnesium alloys through advanced solidification processing [J]. Scr. Mater., 2020, 177: 234 |
| 58 | Niederlaender J, Walter M, Krajewski S, et al. Cytocompatibility evaluation of different biodegradable magnesium alloys with human mesenchymal stem cells [J]. J. Mater. Sci.: Mater. Med., 2014, 25: 835 |
| 59 | Ma J, Zhao N, Zhu D H. Endothelial cellular responses to biodegradable metal zinc [J]. ACS Biomater. Sci. Eng., 2015, 1: 1174 |
| 60 | Shearier E R, Bowen P K, He W L, et al. In vitro cytotoxicity, adhesion, and proliferation of human vascular cells exposed to zinc [J]. ACS Biomater. Sci. Eng., 2016, 2: 634 |
| 61 | Kubásek J, Vojtěch D, Jablonská E, et al. Structure, mechanical characteristics and in vitro degradation, cytotoxicity, genotoxicity and mutagenicity of novel biodegradable Zn-Mg alloys [J]. Mater. Sci. Eng., 2016, C58: 24 |
| 62 | Jablonská E, Vojtěch D, Fousová M, et al. Influence of surface pre-treatment on the cytocompatibility of a novel biodegradable ZnMg alloy [J]. Mater. Sci. Eng., 2016, C68: 198 |
| 63 | Venezuela J, Dargusch M S. The influence of alloying and fabrication techniques on the mechanical properties, biodegradability and biocompatibility of zinc: A comprehensive review [J]. Acta Biomater., 2019, 87: 1 |
| 64 | Shi Z Z, Yu J, Liu X F, et al. Effects of Ag, Cu or Ca addition on microstructure and comprehensive properties of biodegradable Zn-0.8Mn alloy [J]. Mater. Sci. Eng., 2019, C99: 969 |
| 65 | Li P, Schille C, Schweizer E, et al. Selection of extraction medium influences cytotoxicity of zinc and its alloys [J]. Acta Biomater., 2019, 98: 235 |
| 66 | Reference individuals for use in radiation protection-Part 5: Human body elemental composition and contents of element in main tissues and organs [S]. 2014 |
| 67 | Mostaed E, Sikora-Jasinska M, Drelich J W, et al. Zinc-based alloys for degradable vascular stent applications [J]. Acta Biomater., 2018, 71: 1 |
| 68 | Wang J L, Witte F, Xi T F, et al. Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials [J]. Acta Biomater., 2015, 21: 237 |
| 69 | Boon G D. An overview of hemostasis [J]. Toxicol. Pathol., 1993, 21: 170 |
| 70 | De Gaetano G. Historical overview of the role of platelets in hemostasis and thrombosis [J]. Haematologica, 2001, 86: 349 |
| 71 | Yin Y X, Zhou C, Shi Y P, et al. Hemocompatibility of biodegradable Zn-0.8?wt% (Cu, Mn, Li) alloys [J]. Mater. Sci. Eng., 2019, C104: 109896 |
| 72 | Liu X W, Sun J K, Zhou F Y, et al. Micro-alloying with Mn in Zn-Mg alloy for future biodegradable metals application [J]. Mater. Des., 2016, 94: 95 |
| 73 | Shen C, Liu X W, Fan B, et al. Mechanical properties, in vitro degradation behavior, hemocompatibility and cytotoxicity evaluation of Zn-1.2Mg alloy for biodegradable implants [J]. RSC Adv., 2016, 6: 86410 |
| 74 | Liu X W, Sun J K, Yang Y H, et al. Microstructure, mechanical properties, in vitro degradation behavior and hemocompatibility of novel Zn-Mg-Sr alloys as biodegradable metals [J]. Mater. Lett., 2016, 162: 242 |
| 75 | Bowen P K, Drelich J, Goldman J. Zinc exhibits ideal physiological corrosion behavior for bioabsorbable stents [J]. Adv. Mater., 2013, 25: 2577 |
| 76 | Bowen P K, Guillory II R J, Shearier E R, et al. Metallic zinc exhibits optimal biocompatibility for bioabsorbable endovascular stents [J]. Mater. Sci. Eng., 2015, C56: 467 |
| 77 | Pierson D, Edick J, Tauscher A, et al. A simplified in vivo approach for evaluating the bioabsorbable behavior of candidate stent materials [J]. J. Biomed. Mater. Res., 2012, 100B: 58 |
| 78 | Yang H T, Wang C, Liu C Q, et al. Evolution of the degradation mechanism of pure zinc stent in the one-year study of rabbit abdominal aorta model [J]. Biomaterials, 2017, 145: 92 |
| 79 | Zhao S, Seitz J M, Eifler R, et al. Zn-Li alloy after extrusion and drawing: Structural, mechanical characterization, and biodegradation in abdominal aorta of rat [J]. Mater. Sci. Eng., 2017, C76: 301 |
| 80 | Jin H L, Zhao S, Guillory R, et al. Novel high-strength, low-alloys Zn-Mg (< 0.1wt% Mg) and their arterial biodegradation [J]. Mater. Sci. Eng., 2018, C84: 67 |
| 81 | Bowen P K, Seitz J M, Guillory II R J, et al. Evaluation of wrought Zn-Al alloys (1, 3, and 5 wt % Al) through mechanical and in vivo testing for stent applications [J]. J. Biomed. Mater. Res., 2018, 106B: 245 |
| 82 | Tang L P, Eaton J W. Inflammatory responses to biomaterials [J]. Am. J. Clin. Pathol., 1995, 103: 466 |
| 83 | Lane J P, Perkins L E L, Sheehy A J, et al. Lumen gain and restoration of pulsatility after implantation of a bioresorbable vascular scaffold in porcine coronary arteries [J]. JACC: Cardiovasc. Interventions, 2014, 7: 688 |
| 84 | Zhou C, Li H F, Yin Y X, et al. Long-term in vivo study of biodegradable Zn-Cu stent: A 2-year implantation evaluation in porcine coronary artery [J]. Acta Biomater., 2019, 97: 657 |
| 85 | Oliver A A, Guillory II R J, Flom K L, et al. Analysis of vascular inflammation against bioresorbable Zn-Ag-based alloys [J]. ACS Appl. Bio Mater., 2020, 3: 6779 |
| 86 | Drelich A J, Zhao S, Guillory II R J, et al. Long-term surveillance of zinc implant in murine artery: Surprisingly steady biocorrosion rate [J]. Acta Biomater., 2017, 58: 539 |
| 87 | Yang H T, Qu X H, Wang M Q, et al. Zn-0.4Li alloy shows great potential for the fixation and healing of bone fractures at load-bearing sites [J]. Chem. Eng. J., 2021, 417: 129317 |
| 88 | Jia B, Yang H T, Han Y, et al. In vitro and in vivo studies of Zn-Mn biodegradable metals designed for orthopedic applications [J]. Acta Biomater., 2020, 108: 358 |
| 89 | Jia B, Yang H T, Zhang Z C, et al. Biodegradable Zn-Sr alloy for bone regeneration in rat femoral condyle defect model: In vitro and in vivo studies [J]. Bioact. Mater., 2021, 6: 1588 |
| 90 | Guo P S, Zhu X L, Yang L J, et al. Ultrafine- and uniform-grained biodegradable Zn-0.5Mn alloy: Grain refinement mechanism, corrosion behavior, and biocompatibility in vivo [J]. Mater. Sci. Eng., 2021, C118: 111391 |
| 91 | Yang H T, Jia B, Zhang Z C, et al. Alloying design of biodegradable zinc as promising bone implants for load-bearing applications [J]. Nat. Commun., 2020, 11: 401 |
| 92 | Guo H, Hu J L, Shen Z Q, et al. In vitro and in vivo studies of biodegradable Zn-Li-Mn alloy staples designed for gastrointestinal anastomosis [J]. Acta Biomater., 2021, 121: 713 |
| 93 | Kafri A, Ovadia S, Yosafovich-Doitch G, et al. In vivo performances of pure Zn and Zn-Fe alloy as biodegradable implants [J]. J. Mater. Sci.: Mater. Med., 2018, 29: 94 |
| 94 | Qu X H, Yang H T, Jia B, et al. Biodegradable Zn-Cu alloys show antibacterial activity against MRSA bone infection by inhibiting pathogen adhesion and biofilm formation [J]. Acta Biomater., 2020, 117: 400 |
| 95 | Lin J X, Tong X, Shi Z M, et al. A biodegradable Zn-1Cu-0.1Ti alloy with antibacterial properties for orthopedic applications [J]. Acta Biomater., 2020, 106: 410 |
| 96 | Lin S, Ran X L, Yan X H, et al. Systematical evolution on a Zn-Mg alloy potentially developed for biodegradable cardiovascular stents [J]. J. Mater. Sci.: Mater. Med., 2019, 30: 122 |
| 97 | Tong X, Shi Z M, Xu L C, et al. Degradation behavior, cytotoxicity, hemolysis, and antibacterial properties of electro-deposited Zn-Cu metal foams as potential biodegradable bone implants [J]. Acta Biomater., 2020, 102: 481 |
| 98 | Peng F, Xie J N, Liu H M, et al. Shifting focus from bacteria to host neutrophil extracellular traps of biodegradable pure Zn to combat implant centered infection [J]. Bioact. Mater., 2023, 21: 436 |
/
| 〈 |
|
〉 |
