DOI: https://doi.org/10.15587/1729-4061.2019.157495

Design and examination of the new biosoluble casting alloy of the system Mg–Zr–Nd for osteosynthesis

Vadim Shalomeev, Nikita Aikin, Vadim Chorniy, Valeriy Naumik

Abstract


We have performed a comparative analysis of existing materials for the fabrication of implants and report their physical-mechanical properties; their advantages and disadvantages have been defined. It is shown that magnesium alloys are among the most promising biosoluble materials. They are bioinert and biocompatible, but their use in osteosynthesis is limited mainly by their inadequate mechanical properties due to the high rate of biodegradation, which requires improving them by changing the chemical composition of the alloy.

In order to develop a new magnesium-based biosoluble alloy, we have selected the most suitable doping systems in accordance with the established criteria.

Employing the methods of experiment design, we studied the separate and joint influence of zirconium, neodymium and zinc on structure formation and mechanical properties of magnesium alloy. Mathematical models have been constructed that describe the influence of the examined alloying elements on the mechanical properties of the metal. Using the regression equations derived, we have carried out the optimization of the chemical composition of magnesium alloy.

The industrial and pre-clinical tests of implants made from the designed biosoluble alloy have been performed. Experiments on animals confirmed the absence of toxic effect from the products of degradation of the devised magnesium alloy on a living organism. Studying the influence of the designed alloy on reparative osteogenesis during experiment on rabbits has shown the positive dynamics of bone tissue regeneration without noticeable changes in its structure, which ensures reliable merging of elements in bones at osteosynthesis.

It was established that the implants made from the designed alloy possess the necessary level of mechanical properties that match the mechanical properties of bone tissue. At the same time, they are non-toxic and provides a secure bone tissue healing until the complete fracture consolidation. Positive results of the experiments conducted allow us to suggest a favorable prognosis on the possibility of using implants made from the devised biosoluble alloy of the system Mg–Zr–Nd in humans

Keywords


alloying elements; experiment design; tensile strength; relative elongation; chemical composition; optimization

References


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Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675) (2013). ASTM International. doi: https://doi.org/10.1520/f1586

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Muzychenko, P. F. (2012). Biomaterials technology problems in traumatology and orthopedics. Travma, 1, 94–98.

Seal, C. K., Vince, K., Hodgson, M. A. (2009). Biodegradable surgical implants based on magnesium alloys – A review of current research. IOP Conference Series: Materials Science and Engineering, 4, 012011. doi: https://doi.org/10.1088/1757-899x/4/1/012011

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Vasenius, J., Vainionpää, S., Vihtonen, K., Mäkelä, A., Rokkanen, P., Mero, M., Törmälä, P. (1990). Comparison of in vitro hydrolysis, subcutaneous and intramedullary implantation to evaluate the strength retention of absorbable osteosynthesis implants. Biomaterials, 11 (7), 501–504. doi: https://doi.org/10.1016/0142-9612(90)90065-x

Pihlajamaki, H., Bostman, O., Hirvensalo, E., Tormala, P., Rokkanen, P. (1992). Absorbable pins of self-reinforced poly-L-lactic acid for fixation of fractures and osteotomies. The Journal of Bone and Joint Surgery. British Volume, 74-B (6), 853–857. doi: https://doi.org/10.1302/0301-620x.74b6.1447246

Lauer, G., Pradel, W., Leonhardt, H., Loukota, R., Eckelt, U. (2010). Resorbable triangular plate for osteosynthesis of fractures of the condylar neck. British Journal of Oral and Maxillofacial Surgery, 48 (7), 532–535. doi: https://doi.org/10.1016/j.bjoms.2009.10.008

Bergsma, J. E., Bruijn, W. C., Rozema, F. R., Bos, R. R. M., Boering, G. (1995). Late degradation tissue response to poly(L-lactide) bone plates and screws. Biomoterials, 16 (1), 25–31. doi: https://doi.org/10.1016/0142-9612(95)91092-d

Böstman, O. M. (1998). Osteoarthritis of the ankle after foreign-body reaction to absorbable pins and screws. The Journal of Bone and Joint Surgery. British Volume, 80-B (2), 333–338. doi: https://doi.org/10.1302/0301-620x.80b2.0800333

Schumann, P., Lindhorst, D., Wagner, M. E. H., Schramm, A., Gellrich, N.-C., Rücker, M. (2013). Perspectives on Resorbable Osteosynthesis Materials in Craniomaxillofacial Surgery. Pathobiology, 80 (4), 211–217. doi: https://doi.org/10.1159/000348328

Türesin, F., Gürsel, I., Hasirci, V. (2001). Biodegradable polyhydroxyalkanoate implants for osteomyelitis therapy: in vitro antibiotic release. Journal of Biomaterials Science, Polymer Edition, 12 (2), 195–207. doi: https://doi.org/10.1163/156856201750180924

Chen, G.-Q., Wu, Q. (2005). The application of polyhydroxyalkanoates as tissue engineering materials. Biomaterials, 26 (33), 6565–6578. doi: https://doi.org/10.1016/j.biomaterials.2005.04.036

Philip, S., Keshavarz, T., Roy, I. (2007). Polyhydroxyalkanoates: biodegradable polymers with a range of applications. Journal of Chemical Technology & Biotechnology, 82 (3), 233–247. doi: https://doi.org/10.1002/jctb.1667

Berins, L. M. (2000). SPI Plastics Engineering Handbook of the Society of the Plastics Industry. Springer.

Barinov, S. M. (2010). Calcium phosphate-based ceramic and composite materials for medicine. Russian Chemical Reviews, 79 (1), 13–29. doi: https://doi.org/10.1070/rc2010v079n01abeh004098

Barakat, N. A. M., Khil, M. S., Omran, A. M., Sheikh, F. A., Kim, H. Y. (2009). Extraction of pure natural hydroxyapatite from the bovine bones bio waste by three different methods. Journal of Materials Processing Technology, 209 (7), 3408–3415. doi: https://doi.org/10.1016/j.jmatprotec.2008.07.040

Heise, U., Osborn, J. F., Duwe, F. (1990). Hydroxyapatite ceramic as a bone substitute. International Orthopaedics, 14 (3). doi: https://doi.org/10.1007/bf00178768

Qiu, H., Yang, J., Kodali, P., Koh, J., Ameer, G. A. (2006). A citric acid-based hydroxyapatite composite for orthopedic implants. Biomaterials, 27 (34), 5845–5854. doi: https://doi.org/10.1016/j.biomaterials.2006.07.042

Li, J., Lu, X. L., Zheng, Y. F. (2008). Effect of surface modified hydroxyapatite on the tensile property improvement of HA/PLA composite. Applied Surface Science, 255 (2), 494–497. doi: https://doi.org/10.1016/j.apsusc.2008.06.067

Shikinami, Y., Okuno, M. (1999). Bioresorbable devices made of forged composites of hydroxyapatite (HA) particles and poly-L-lactide (PLLA): Part I. Basic characteristics. Biomaterials, 20 (9), 859–877. doi: https://doi.org/10.1016/s0142-9612(98)00241-5

Staiger, M. P., Pietak, A. M., Huadmai, J., Dias, G. (2006). Magnesium and its alloys as orthopedic biomaterials: A review. Biomaterials, 27 (9), 1728–1734. doi: https://doi.org/10.1016/j.biomaterials.2005.10.003

Eydenzon, M. A. (1969). Magniy. Moscow: Metallurgiya, 351.

Karpov, V. G., Shahov, V. P. (2001). Sistemy vneshney fiksacii i regulyatornye mekhanizmy optimal'noy biomekhaniki. Moscow: SST.

Song, G. (2007). Control of biodegradation of biocompatable magnesium alloys. Corrosion Science, 49 (4), 1696–1701. doi: https://doi.org/10.1016/j.corsci.2007.01.001

Witte, F., Kaese, V., Haferkamp, H., Switzer, E., Meyer-Lindenberg, A., Wirth, C. J., Windhagen, H. (2005). In vivo corrosion of four magnesium alloys and the associated bone response. Biomaterials, 26 (17), 3557–3563. doi: https://doi.org/10.1016/j.biomaterials.2004.09.049

Song, G., Song, S. (2007). A Possible Biodegradable Magnesium Implant Material. Advanced Engineering Materials, 9 (4), 298–302. doi: https://doi.org/10.1002/adem.200600252

Samarskiy, A. A., Mihaylov, A. P. (2001). Matematicheskoe modelirovanie. Moscow: Fizmatlit, 320.

Velikiy, V. I., Yares’ko, K. I., Shalomeev, V. A., Tsivirko, E. I., Vnukov, Y. N. (2014). Prospective Magnesium Alloys with Elevated Level of Properties for the Aircraft Engine Industry. Metal Science and Heat Treatment, 55 (9-10), 492–498. doi: https://doi.org/10.1007/s11041-014-9660-x

Shalomeev, V., Tsivirco, E., Vnukov, Y., Osadchaya, Y., Makovskyi, S. (2016). Development of new casting magnesium-based alloys with increased mechanical properties. Eastern-European Journal of Enterprise Technologies, 4 (1 (82)), 4–10. doi: https://doi.org/10.15587/1729-4061.2016.73384

GOST 2856-79. Splavy magnievye liteynye. Marki (1981). Moscow: Izdatel'stvo standartov.

Xingwei, Z., Jie, D., Wencai, L., Wenjiang, D. (2011). Microstructure and mechanical properties of NZ30K alloy by semicontinuous direct chill and sand mould casting processes. China foundry, 8 (1), 41–46.

Turowska, A., Adamiec, J. (2015). Mechanical Properties of WE43 Magnesium Alloy Joint at Elevated Temperature / Właściwości Mechaniczne Złączy Ze Stopu Magnezu WE43 W Podwyższonej Temperaturze. Archives of Metallurgy and Materials, 60 (4), 2695–2702. doi: https://doi.org/10.1515/amm-2015-0434

Gill, L., Lorimer, G. W., Lyon, P. (2005). Microstructure/Property Relationships of Three Mg-RE-Zn-Zr Alloys. Magnesium, 421–426. doi: https://doi.org/10.1002/3527603565.ch66

Koltygin, A. V. (2013). Analiz vozmozhnyh fazovyh prevrashcheniy pri kristalizacii i ih vliyanie na liteynuyu strukturu v splave ML10. Metallovedenie i termicheskaya obrabotka metallov, 8, 25–28.


GOST Style Citations


Hayes J., Richards R. The use of titanium and stainless steel in fracture fixation // Expert Review of Medical Devices. 2010. Vol. 7, Issue 6. P. 843–853. doi: https://doi.org/10.1586/erd.10.53 

Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675) // ASTM International. 2013. doi: https://doi.org/10.1520/f1586 

Biomimetic porous scaffolds for bone tissue engineering / Wu S., Liu X., Yeung K. W. K., Liu C., Yang X. // Materials Science and Engineering: R: Reports. 2014. Vol. 80. P. 1–36. doi: https://doi.org/10.1016/j.mser.2014.04.001 

Muzychenko P. F. Biomaterials technology problems in traumatology and orthopedics // Travma. 2012. Issue 1. P. 94–98.

Seal C. K., Vince K., Hodgson M. A. Biodegradable surgical implants based on magnesium alloys – A review of current research // IOP Conference Series: Materials Science and Engineering. 2009. Vol. 4. P. 012011. doi: https://doi.org/10.1088/1757-899x/4/1/012011 

Reinforced bioresorbable implants for craniomaxillofacial osteosynthesis in pigs / Chen C.-H., Shyu V. B.-H., Chen Y.-C., Liao H.-T., Liao C.-J., Chen C.-T. // British Journal of Oral and Maxillofacial Surgery. 2013. Vol. 51, Issue 8. P. 948–952. doi: https://doi.org/10.1016/j.bjoms.2013.07.011 

Comparison of in vitro hydrolysis, subcutaneous and intramedullary implantation to evaluate the strength retention of absorbable osteosynthesis implants / Vasenius J., Vainionpää S., Vihtonen K., Mäkelä A., Rokkanen P., Mero M., Törmälä P. // Biomaterials. 1990. Vol. 11, Issue 7. P. 501–504. doi: https://doi.org/10.1016/0142-9612(90)90065-x 

Absorbable pins of self-reinforced poly-L-lactic acid for fixation of fractures and osteotomies / Pihlajamaki H., Bostman O., Hirvensalo E., Tormala P., Rokkanen P. // The Journal of Bone and Joint Surgery. British volume. 1992. Vol. 74-B, Issue 6. P. 853–857. doi: https://doi.org/10.1302/0301-620x.74b6.1447246 

Resorbable triangular plate for osteosynthesis of fractures of the condylar neck / Lauer G., Pradel W., Leonhardt H., Loukota R., Eckelt U. // British Journal of Oral and Maxillofacial Surgery. 2010. Vol. 48, Issue 7. P. 532–535. doi: https://doi.org/10.1016/j.bjoms.2009.10.008 

Late degradation tissue response to poly(L-lactide) bone plates and screws / Bergsma J. E., Bruijn W. C., Rozema F. R., Bos R. R. M., Boering G. // Biomoterials. 1995. Vol. 16, Issue 1. P. 25–31. doi: https://doi.org/10.1016/0142-9612(95)91092-d 

Böstman O. M. Osteoarthritis of the ankle after foreign-body reaction to absorbable pins and screws // The Journal of Bone and Joint Surgery. British volume. 1998. Vol. 80-B, Issue 2. P. 333–338. doi: https://doi.org/10.1302/0301-620x.80b2.0800333 

Perspectives on Resorbable Osteosynthesis Materials in Craniomaxillofacial Surgery / Schumann P., Lindhorst D., Wagner M. E. H., Schramm A., Gellrich N.-C., Rücker M. // Pathobiology. 2013. Vol. 80, Issue 4. P. 211–217. doi: https://doi.org/10.1159/000348328 

Türesin F., Gürsel I., Hasirci V. Biodegradable polyhydroxyalkanoate implants for osteomyelitis therapy: in vitro antibiotic release // Journal of Biomaterials Science, Polymer Edition. 2001. Vol. 12, Issue 2. P. 195–207. doi: https://doi.org/10.1163/156856201750180924 

Chen G.-Q., Wu Q. The application of polyhydroxyalkanoates as tissue engineering materials // Biomaterials. 2005. Vol. 26, Issue 33. P. 6565–6578. doi: https://doi.org/10.1016/j.biomaterials.2005.04.036 

Philip S., Keshavarz T., Roy I. Polyhydroxyalkanoates: biodegradable polymers with a range of applications // Journal of Chemical Technology & Biotechnology. 2007. Vol. 82, Issue 3. P. 233–247. doi: https://doi.org/10.1002/jctb.1667 

Berins L. M. SPI Plastics Engineering Handbook of the Society of the Plastics Industry. 5th ed. Springer, 2000.

Barinov S. M. Calcium phosphate-based ceramic and composite materials for medicine // Russian Chemical Reviews. 2010. Vol. 79, Issue 1. P. 13–29. doi: https://doi.org/10.1070/rc2010v079n01abeh004098 

Extraction of pure natural hydroxyapatite from the bovine bones bio waste by three different methods / Barakat N. A. M., Khil M. S., Omran A. M., Sheikh F. A., Kim H. Y. // Journal of Materials Processing Technology. 2009. Vol. 209, Issue 7. P. 3408–3415. doi: https://doi.org/10.1016/j.jmatprotec.2008.07.040 

Heise U., Osborn J. F., Duwe F. Hydroxyapatite ceramic as a bone substitute // International Orthopaedics. 1990. Vol. 14, Issue 3. doi: https://doi.org/10.1007/bf00178768 

A citric acid-based hydroxyapatite composite for orthopedic implants / Qiu H., Yang J., Kodali P., Koh J., Ameer G. A. // Biomaterials. 2006. Vol. 27, Issue 34. P. 5845–5854. doi: https://doi.org/10.1016/j.biomaterials.2006.07.042 

Li J., Lu X. L., Zheng Y. F. Effect of surface modified hydroxyapatite on the tensile property improvement of HA/PLA composite // Applied Surface Science. 2008. Vol. 255, Issue 2. P. 494–497. doi: https://doi.org/10.1016/j.apsusc.2008.06.067 

Shikinami Y., Okuno M. Bioresorbable devices made of forged composites of hydroxyapatite (HA) particles and poly-L-lactide (PLLA): Part I. Basic characteristics // Biomaterials. 1999. Vol. 20, Issue 9. P. 859–877. doi: https://doi.org/10.1016/s0142-9612(98)00241-5 

Magnesium and its alloys as orthopedic biomaterials: A review / Staiger M. P., Pietak A. M., Huadmai J., Dias G. // Biomaterials. 2006. Vol. 27, Issue 9. P. 1728–1734. doi: https://doi.org/10.1016/j.biomaterials.2005.10.003 

Eydenzon M. A. Magniy. Moscow: Metallurgiya, 1969. 351 p.

Karpov V. G., Shahov V. P. Sistemy vneshney fiksacii i regulyatornye mekhanizmy optimal'noy biomekhaniki. Moscow: SST, 2001.

Song G. Control of biodegradation of biocompatable magnesium alloys // Corrosion Science. 2007. Vol. 49, Issue 4. P. 1696–1701. doi: https://doi.org/10.1016/j.corsci.2007.01.001 

In vivo corrosion of four magnesium alloys and the associated bone response / Witte F., Kaese V., Haferkamp H., Switzer E., Meyer-Lindenberg A., Wirth C. J., Windhagen H. // Biomaterials. 2005. Vol. 26, Issue 17. P. 3557–3563. doi: https://doi.org/10.1016/j.biomaterials.2004.09.049 

Song G., Song S. A Possible Biodegradable Magnesium Implant Material // Advanced Engineering Materials. 2007. Vol. 9, Issue 4. P. 298–302. doi: https://doi.org/10.1002/adem.200600252 

Samarskiy A. A., Mihaylov A. P. Matematicheskoe modelirovanie. Moscow: Fizmatlit, 2001. 320 p.

Prospective Magnesium Alloys with Elevated Level of Properties for the Aircraft Engine Industry / Velikiy V. I., Yares’ko K. I., Shalomeev V. A., Tsivirko E. I., Vnukov Y. N. // Metal Science and Heat Treatment. 2014. Vol. 55, Issue 9-10. P. 492–498. doi: https://doi.org/10.1007/s11041-014-9660-x 

Development of new casting magnesium-based alloys with increased mechanical properties / Shalomeev V., Tsivirco E., Vnukov Y., Osadchaya Y., Makovskyi S. // Eastern-European Journal of Enterprise Technologies. 2016. Vol. 4, Issue 1 (82). P. 4–10. doi: https://doi.org/10.15587/1729-4061.2016.73384 

GOST 2856-79. Splavy magnievye liteynye. Marki. Moscow: Izdatel'stvo standartov, 1981.

Microstructure and mechanical properties of NZ30K alloy by semicontinuous direct chill and sand mould casting processes / Xingwei Z., Jie D., Wencai L., Wenjiang D. // China foundry. 2011. Vol. 8, Issue 1. P. 41–46.

Turowska A., Adamiec J. Mechanical Properties of WE43 Magnesium Alloy Joint at Elevated Temperature / Właściwości Mechaniczne Złączy Ze Stopu Magnezu WE43 W Podwyższonej Temperaturze // Archives of Metallurgy and Materials. 2015. Vol. 60, Issue 4. P. 2695–2702. doi: https://doi.org/10.1515/amm-2015-0434 

Gill L., Lorimer G. W., Lyon P. Microstructure/Property Relationships of Three Mg-RE-Zn-Zr Alloys // Magnesium. 2005. P. 421–426. doi: https://doi.org/10.1002/3527603565.ch66 

Koltygin A. V. Analiz vozmozhnyh fazovyh prevrashcheniy pri kristalizacii i ih vliyanie na liteynuyu strukturu v splave ML10 // Metallovedenie i termicheskaya obrabotka metallov. 2013. Issue 8. P. 25–28.







Copyright (c) 2019 Vadim Shalomeev, Nikita Aikin, Vadim Chorniy, Valeriy Naumik

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ISSN (print) 1729-3774, ISSN (on-line) 1729-4061