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Erschienen in: European Journal of Trauma and Emergency Surgery 5/2022

06.05.2021 | Original Article

Autoclave sterilization of an in-house 3D-printed polylactic acid piece: biological safety and heat-induced deformation

verfasst von: Joan Ferràs-Tarragó, Oihana Sabalza-Baztán, Jose Miguel Sahuquillo-Arce, Manuel Ángel Angulo-Sánchez, Carolina De-La-Calva Ceinos, Jose Vicente Amaya-Valero, Francisco Baixauli-García

Erschienen in: European Journal of Trauma and Emergency Surgery | Ausgabe 5/2022

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Abstract

Aims

Fused filament fabrication 3D printing with polylactic acid filaments is the most widely used method to generate biomodels at hospitals throughout the world. The main limitation of this manufacturing system is related to the biomodels’ temperature sensitivity, which all but prevents them to be sterilized using conventional methods. The purpose of this study is to define an autoclave temperature-resistant FFF-PLA 3D printing protocol to print 3D fractures biomodels during preoperative planning.

Methods and results

Six different printing protocols were established, each with a different infill percentage. Ten distal radius biomodels were printed with each protocol and each biomodel was subject to 3D scanning. The biomodels were subsequently autoclave-sterilized at 134 °C and subjected to a new scanning process, which was followed by a calculation of changes in area, volume and deformity using the Hausdorff–Besicovitch method. Finally, 192 polylactic acid models were produced using the printing protocol offering the greatest resistance and were contaminated with 31 common nosocomial pathogens to evaluate the effectiveness of sterilizing the model printed using the said protocol. Sterilization resulted in a mean deformation of the biomodel of 0.14 mm, a maximum deformity of 0.75 mm, and a 1% area and a 3.6% volume reduction. Sterilization of the pieces printed using the analyzed protocol was 100% effective.

Conclusions

The analyzed 3D printing protocol may be applied with any FFF-PLA 3D printer, it is safe and does not significantly alter the morphology of biomodels. These results indicate that 3D printing is associated with significant advantages for health centers as it increases their autonomy, allowing them to easily produce 3D biomodels that can be used for the treatment of fractures.
Literatur
1.
Zurück zum Zitat Tack P, Victor J, Gemmel P, Annemans L. 3D-printing techniques in a medical setting: a systematic literature review. Biomed Eng Online. 2016;15(1):115. CrossRef Tack P, Victor J, Gemmel P, Annemans L. 3D-printing techniques in a medical setting: a systematic literature review. Biomed Eng Online. 2016;15(1):115. CrossRef
2.
Zurück zum Zitat Auricchio F, Marconi S. 3D printing: clinical applications in orthopaedics and traumatology. EFORT Open Reviews. 2016;1(5):121–7. CrossRef Auricchio F, Marconi S. 3D printing: clinical applications in orthopaedics and traumatology. EFORT Open Reviews. 2016;1(5):121–7. CrossRef
3.
Zurück zum Zitat Vaishya R, Patralekh MK, Vaish A, Agarwal AK, Vijay V. Publication trends and knowledge mapping in 3D printing in orthopaedics. J Clin Orthop Trauma. 2018;9(3):194–201. CrossRef Vaishya R, Patralekh MK, Vaish A, Agarwal AK, Vijay V. Publication trends and knowledge mapping in 3D printing in orthopaedics. J Clin Orthop Trauma. 2018;9(3):194–201. CrossRef
4.
Zurück zum Zitat Wong KC, Kumta SM, Geel NV, Demol J. One-step reconstruction with a 3D-printed, biomechanically evaluated custom implant after complex pelvic tumor resection. Computer Aided Surg. 2015;20(1):14–23 ( New York, NY). CrossRef Wong KC, Kumta SM, Geel NV, Demol J. One-step reconstruction with a 3D-printed, biomechanically evaluated custom implant after complex pelvic tumor resection. Computer Aided Surg. 2015;20(1):14–23 ( New York, NY). CrossRef
5.
Zurück zum Zitat Bizzotto N, Tami I, Santucci A, Adani R, Poggi P, Romani D, et al. 3D printed replica of articular fractures for surgical planning and patient consent: a two years multi-centric experience. 3D Print Med. 2016;2(1):1–6. CrossRef Bizzotto N, Tami I, Santucci A, Adani R, Poggi P, Romani D, et al. 3D printed replica of articular fractures for surgical planning and patient consent: a two years multi-centric experience. 3D Print Med. 2016;2(1):1–6. CrossRef
6.
Zurück zum Zitat Zheng W, Su J, Cai L, Lou Y, Wang J, Guo X, et al. Application of 3D-printing technology in the treatment of humeral intercondylar fractures. Orthop Traumatol Surg Res. 2018;104(1):83–8. CrossRef Zheng W, Su J, Cai L, Lou Y, Wang J, Guo X, et al. Application of 3D-printing technology in the treatment of humeral intercondylar fractures. Orthop Traumatol Surg Res. 2018;104(1):83–8. CrossRef
7.
Zurück zum Zitat Wang Q, Hu J, Guan J, Chen Y, Wang L. Proximal third humeral shaft fractures fixed with long helical PHILOS plates in elderly patients: benefit of pre-contouring plates on a 3D-printed model—a retrospective study. J Orthop Surg Res. 2018;13(1):203. CrossRef Wang Q, Hu J, Guan J, Chen Y, Wang L. Proximal third humeral shaft fractures fixed with long helical PHILOS plates in elderly patients: benefit of pre-contouring plates on a 3D-printed model—a retrospective study. J Orthop Surg Res. 2018;13(1):203. CrossRef
8.
Zurück zum Zitat Xie L, Chen C, Zhang Y, Zheng W, Chen H, Cai L. Three-dimensional printing assisted ORIF versus conventional ORIF for tibial plateau fractures: a systematic review and meta-analysis. Int J Surg. 2018;57:35–44. CrossRef Xie L, Chen C, Zhang Y, Zheng W, Chen H, Cai L. Three-dimensional printing assisted ORIF versus conventional ORIF for tibial plateau fractures: a systematic review and meta-analysis. Int J Surg. 2018;57:35–44. CrossRef
9.
Zurück zum Zitat Ferràs-Tarragó J, Sanchis-Alfonso V, Ramírez-Fuentes C, Roselló-Añón A, Baixauli-García F. A 3D-CT analysis of femoral symmetry—surgical implications. J Clin Med. 2020;9(11):3546. CrossRef Ferràs-Tarragó J, Sanchis-Alfonso V, Ramírez-Fuentes C, Roselló-Añón A, Baixauli-García F. A 3D-CT analysis of femoral symmetry—surgical implications. J Clin Med. 2020;9(11):3546. CrossRef
10.
Zurück zum Zitat Ferràs-Tarragó J, Sanchis-Alfonso V, Ramírez-Fuentes C, Roselló-Añón A, Baixauli-García F. Locating the origin of femoral maltorsion using 3D volumetric technology—the Hockey stick theory. J Clin Med. 2020;9(12):3835. CrossRef Ferràs-Tarragó J, Sanchis-Alfonso V, Ramírez-Fuentes C, Roselló-Añón A, Baixauli-García F. Locating the origin of femoral maltorsion using 3D volumetric technology—the Hockey stick theory. J Clin Med. 2020;9(12):3835. CrossRef
11.
Zurück zum Zitat Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2014;98(2):159–61. CrossRef Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2014;98(2):159–61. CrossRef
12.
Zurück zum Zitat Liu S, Wu G, Chen X, Zhang X, Yu J, Liu M, et al. Degradation behavior in vitro of carbon nanotubes (CNTs)/poly(lactic acid) (PLA) composite suture. Polymers. 2019;11(6):1015. CrossRef Liu S, Wu G, Chen X, Zhang X, Yu J, Liu M, et al. Degradation behavior in vitro of carbon nanotubes (CNTs)/poly(lactic acid) (PLA) composite suture. Polymers. 2019;11(6):1015. CrossRef
13.
Zurück zum Zitat Singhvi MS, Zinjarde SS, Gokhale DV. Polylactic acid: synthesis and biomedical applications. J Appl Microbiol. 2019;127(6):1612–26. CrossRef Singhvi MS, Zinjarde SS, Gokhale DV. Polylactic acid: synthesis and biomedical applications. J Appl Microbiol. 2019;127(6):1612–26. CrossRef
14.
Zurück zum Zitat Liu S, Yu J, Li H, Wang K, Wu G, Wang B, et al. Controllable drug release behavior of polylactic acid (PLA) surgical suture coating with ciprofloxacin (CPFX)-polycaprolactone (PCL)/polyglycolide (PGA). Polymers. 2020;12(2):288. CrossRef Liu S, Yu J, Li H, Wang K, Wu G, Wang B, et al. Controllable drug release behavior of polylactic acid (PLA) surgical suture coating with ciprofloxacin (CPFX)-polycaprolactone (PCL)/polyglycolide (PGA). Polymers. 2020;12(2):288. CrossRef
15.
Zurück zum Zitat Tyler B, Gullotti D, Mangraviti A, Utsuki T, Brem H. Polylactic acid (PLA) controlled delivery carriers for biomedical applications. Adv Drug Deliv Rev. 2016;107:163–75. CrossRef Tyler B, Gullotti D, Mangraviti A, Utsuki T, Brem H. Polylactic acid (PLA) controlled delivery carriers for biomedical applications. Adv Drug Deliv Rev. 2016;107:163–75. CrossRef
16.
Zurück zum Zitat Shintani H. Ethylene oxide gas sterilization of medical devices. Biocontrol Sci. 2017;22(1):1–16. CrossRef Shintani H. Ethylene oxide gas sterilization of medical devices. Biocontrol Sci. 2017;22(1):1–16. CrossRef
17.
Zurück zum Zitat Shaheen E, Alhelwani A, Van De Casteele E, Politis C, Jacobs R. Evaluation of dimensional changes of 3D printed models after sterilization: a pilot study. Open Dent J. 2018;12(1):72–9. CrossRef Shaheen E, Alhelwani A, Van De Casteele E, Politis C, Jacobs R. Evaluation of dimensional changes of 3D printed models after sterilization: a pilot study. Open Dent J. 2018;12(1):72–9. CrossRef
18.
Zurück zum Zitat Zhao Y, Zhu B, Wang Y, Liu C, Shen C. Effect of different sterilization methods on the properties of commercial biodegradable polyesters for single-use, disposable medical devices. Mater Sci Eng C. 2019;105:110041. CrossRef Zhao Y, Zhu B, Wang Y, Liu C, Shen C. Effect of different sterilization methods on the properties of commercial biodegradable polyesters for single-use, disposable medical devices. Mater Sci Eng C. 2019;105:110041. CrossRef
19.
Zurück zum Zitat Savaris M, Santos VD, Brandalise RN. Influence of different sterilization processes on the properties of commercial poly(lactic acid). Mater Sci Eng C. 2016;69:661–7. CrossRef Savaris M, Santos VD, Brandalise RN. Influence of different sterilization processes on the properties of commercial poly(lactic acid). Mater Sci Eng C. 2016;69:661–7. CrossRef
20.
Zurück zum Zitat Aguado-Maestro I, De Frutos-Serna M, González-Nava A, Merino-De Santos AB, García-Alonso M. Are the common sterilization methods completely effective for our in-house 3D printed biomodels and surgical guides? Injury 2020 Aguado-Maestro I, De Frutos-Serna M, González-Nava A, Merino-De Santos AB, García-Alonso M. Are the common sterilization methods completely effective for our in-house 3D printed biomodels and surgical guides? Injury 2020
22.
Zurück zum Zitat Cignoni P, Callieri M, Corsini M, Dellepiane M, Ganovelli F, Ranzuglia G. MeshLab: an open-source mesh processing tool. In: Eurographics Italian Chapter Conference 2008, pp. 129–136 (2008). Cignoni P, Callieri M, Corsini M, Dellepiane M, Ganovelli F, Ranzuglia G. MeshLab: an open-source mesh processing tool. In: Eurographics Italian Chapter Conference 2008, pp. 129–136 (2008).
23.
Zurück zum Zitat Foo GL, Kwek EBK Are three-dimensional printed models useful for preoperative planning of tibial plafond fractures? J Foot Ankle Surg. 2019;58(4):723–729. CrossRef Foo GL, Kwek EBK Are three-dimensional printed models useful for preoperative planning of tibial plafond fractures? J Foot Ankle Surg. 2019;58(4):723–729. CrossRef
24.
Zurück zum Zitat Xiong L, Li X, Li H, Chen Z, Xiao T. The efficacy of 3D printing-assisted surgery for traumatic fracture: a meta-analysis. Postgrad Med J. 2019;95(1126):414–9. CrossRef Xiong L, Li X, Li H, Chen Z, Xiao T. The efficacy of 3D printing-assisted surgery for traumatic fracture: a meta-analysis. Postgrad Med J. 2019;95(1126):414–9. CrossRef
25.
Zurück zum Zitat Kang HJ, Kim BS, Kim SM, Kim YM, Kim HN, Park JY, et al. Can preoperative 3D printing change surgeon’s operative plan for distal tibia fracture? Biomed Res Int. 2019;2019:1–7. Kang HJ, Kim BS, Kim SM, Kim YM, Kim HN, Park JY, et al. Can preoperative 3D printing change surgeon’s operative plan for distal tibia fracture? Biomed Res Int. 2019;2019:1–7.
26.
Zurück zum Zitat Boursier J, Fournet A, Bassanino J, Manassero M, Bedu A, Leperlier D. Reproducibility, accuracy and effect of autoclave sterilization on a thermoplastic three-dimensional model printed by a desktop fused deposition modelling three-dimensional printer. Vet Comparative Orthop Traumatol. 2018;31(6):422–30. CrossRef Boursier J, Fournet A, Bassanino J, Manassero M, Bedu A, Leperlier D. Reproducibility, accuracy and effect of autoclave sterilization on a thermoplastic three-dimensional model printed by a desktop fused deposition modelling three-dimensional printer. Vet Comparative Orthop Traumatol. 2018;31(6):422–30. CrossRef
27.
Zurück zum Zitat Standau T, Long H, Murillo Castellón S, Brütting C, Bonten C, Altstädt V. Evaluation of the zero shear viscosity, the D-content and processing conditions as foam relevant parameters for autoclave foaming of standard polylactide (PLA). Materials. 2020;13(6):1371. CrossRef Standau T, Long H, Murillo Castellón S, Brütting C, Bonten C, Altstädt V. Evaluation of the zero shear viscosity, the D-content and processing conditions as foam relevant parameters for autoclave foaming of standard polylactide (PLA). Materials. 2020;13(6):1371. CrossRef
28.
Zurück zum Zitat Zolfagharian A, Khosravani MR, Kaynak A. Fracture resistance analysis of 3D-printed polymers. Polymers. 2020;12(2):302. CrossRef Zolfagharian A, Khosravani MR, Kaynak A. Fracture resistance analysis of 3D-printed polymers. Polymers. 2020;12(2):302. CrossRef
29.
Zurück zum Zitat Török G, Gombocz P, Bognár E, Nagy P, Dinya E, Kispélyi B, et al. Effects of disinfection and sterilization on the dimensional changes and mechanical properties of 3D printed surgical guides for implant therapy—pilot study. BMC Oral Health. 2020;20(1):19. CrossRef Török G, Gombocz P, Bognár E, Nagy P, Dinya E, Kispélyi B, et al. Effects of disinfection and sterilization on the dimensional changes and mechanical properties of 3D printed surgical guides for implant therapy—pilot study. BMC Oral Health. 2020;20(1):19. CrossRef
Metadaten
Titel
Autoclave sterilization of an in-house 3D-printed polylactic acid piece: biological safety and heat-induced deformation
verfasst von
Joan Ferràs-Tarragó
Oihana Sabalza-Baztán
Jose Miguel Sahuquillo-Arce
Manuel Ángel Angulo-Sánchez
Carolina De-La-Calva Ceinos
Jose Vicente Amaya-Valero
Francisco Baixauli-García
Publikationsdatum
06.05.2021
Verlag
Springer Berlin Heidelberg
Erschienen in
European Journal of Trauma and Emergency Surgery / Ausgabe 5/2022
Print ISSN: 1863-9933
Elektronische ISSN: 1863-9941
DOI
https://doi.org/10.1007/s00068-021-01672-6

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