Does vaporized hydrogen peroxide sterilization affect the geometrical properties of anatomic models and guides 3D printed from computed tomography images?
Tóm tắt
Material extrusion is used to 3D print anatomic models and guides. Sterilization is required if a 3D printed part touches the patient during an intervention. Vaporized Hydrogen Peroxide (VHP) is one method of sterilization. There are four factors to consider when sterilizing an anatomic model or guide: sterility, biocompatibility, mechanical properties, and geometric fidelity. This project focuses on geometric fidelity for material extrusion of one polymer acrylonitrile butadiene styrene (ABS) using VHP. De-identified computed tomography (CT) image data from 16 patients was segmented using Mimics Innovation Suite (Materialise NV, Leuven, Belgium). Eight patients had maxillary and mandibular defects depicted with the anatomic models, and eight had mandibular defects for the anatomic guides. Anatomic models and guides designed from the surfaces of CT scan reconstruction and segementation were 3D printed in medical-grade acrylonitrile butadiene styrene (ABS) material extrusion. The 16 parts underwent low-temperature sterilization with VHP. The dimensional error was estimated after sterilization by comparing scanned images of the 3D printed parts. The average of the estimated mean differences between the printed pieces before and after sterilization were − 0,011 ± 0,252 mm (95%CI − 0,011; − 0,010) for the models and 0,003 ± 0,057 mm (95%CI 0,002; 0,003) for the guides. Regarding the dimensional error of the sterilized parts compared to the original design, the estimated mean differences were − 0,082 ± 0,626 mm (95%CI − 0,083; − 0,081) for the models and 0,126 ± 0,205 mm (95%CI 0,126, 0,127) for the guides. This project tested and verified dimensional stability, one of the four prerequisites for introducing vaporized hydrogen peroxide into 3D printing of anatomic models and guides; the 3D printed parts maintained dimensional stability after sterilization.
Tài liệu tham khảo
Jiménez Ormabera B, Díez Valle R, Zaratiegui Fernández J, Llorente Ortega M, Unamuno Iñurritegui X, Tejada SS. Impresión 3 D en neurocirugía: modelo específico para pacientes con craneosinostosis. Neurocirugia. 2017;28(6):260–5. https://doi.org/10.1016/j.neucir.2017.05.001.
Haffner M, Quinn A, Hsieh T, Strong EB, Steele T. Optimization of 3D print material for the recreation of patient-specific temporal bone models. Ann Otol Rhinol Laryngol. 2018;127(5):338–43. https://doi.org/10.1177/0003489418764987.
Ganguli A, Pagan-Diaz GJ, Grant L, Cvetkovic C, Bramlet M, Vozenilek J, et al. 3D printing for preoperative planning and surgical training: a review. Biomed Microdevices. 2018;20(3):65. https://doi.org/10.1007/s10544-018-0301-9.
Antony AK, Chen WF, Kolokythas A, Weimer KA, Cohen MN. Use of virtual surgery and Stereolithography-guided osteotomy for mandibular reconstruction with the free fibula. Plast Reconstr Surg. 2011;128(5):1080–4. https://doi.org/10.1097/PRS.0b013e31822b6723.
Kass JI, Prisman E, Miles BA. Guide design in virtual planning for scapular tip free flap reconstruction. Laryngoscope Investig Otolaryngol. 2018;3(3):162–8 Available from: http://doi.wiley.com/10.1002/lio2.162.
Mitsouras D, Liacouras P, Imanzadeh A, Giannopoulos AA, Cai T, Kumamaru KK, et al. Medical 3D printing for the radiologist. RadioGraphics. 2015;35(7):1965–88 Available from: http://pubs.rsna.org/doi/10.1148/rg.2015140320.
Mitsouras D, Liacouras PC, Wake N, Rybicki FJ. RadioGraphics update: medical 3D printing for the radiologist. RadioGraphics. 2020;40(4):E21–3. Available from. https://doi.org/10.1148/rg.2020190217.
George E, Liacouras P, Rybicki FJ, Mitsouras D. Measuring and establishing the accuracy and reproducibility of 3D printed medical models. RadioGraphics. 2017;37(5):1424–50. Available from. https://doi.org/10.1148/rg.2017160165.
Christensen A, Rybicki FJ. Maintaining safety and efficacy for 3D printing in medicine. 3D Print Med. 2017;3(1):1 Available from: https://threedmedprint.biomedcentral.com/articles/10.1186/s41205-016-0009-5.
Alexander AE, Wake N, Chepelev L, Brantner P, Ryan J, Wang KC. A guideline for 3D printing terminology in biomedical research utilizing ISO/ASTM standards. 3D Print Med. 2021;7(1):8 Available from: https://threedmedprint.biomedcentral.com/articles/10.1186/s41205-021-00098-5.
Shea GK-H, Wu KL-K, Li IW-S, Leung M-F, Ko AL-P, Tse L, et al. A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively. 3D Print Med. 2020;6(1):7.
Gür Y. Additive manufacturing of anatomical models from computed tomography scan data. MCB Mol Cell Biomech. 2015;11(4):249–58.
Popescu D, Vlasceanu D, Cursaru L, Baciu F, Hadar A. Low-temperature sterilization influence on fused deposition modelling parts. Proc Manuf Syst. 2016;11(3):151–8.
Popescu D, Baciu F, Vlăsceanu D, Cotruţ CM, Marinescu R. Effects of multiple sterilizations and natural aging on the mechanical behavior of 3D-printed ABS. Mech Mater. 2020;148(May):103423. https://doi.org/10.1016/j.mechmat.2020.103423.
McEvoy B, Rowan NJ. Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities. J Appl Microbiol. 2019;127(5):1403–20. https://doi.org/10.1111/jam.14412.
US-FDA. Use of International Standard ISO 10993-1, “Biological evaluation of medical devices-Part 1: evaluation and testing within a risk management process” guidance for industry and Food and Drug Administration staff. US Dep Heal Hum Serv Food Drug Adm. 2020;(301):1–68 Available from: https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-%0Ahttp://www.fda.gov.proxy1.library.jhu.edu/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf.
Chepelev L, Wake N, Ryan J, Althobaity W, Gupta A, Arribas E, et al. Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. 3D Print Med. 2018;4(1):11.
Malik HH, Darwood ARJ, Shaunak S, Kulatilake P, El-Hilly AA, Mulki O, et al. Three-dimensional printing in surgery: a review of current surgical applications. J Surg Res. 2015;199(2):512–22. https://doi.org/10.1016/j.jss.2015.06.051.
Kim GB, Lee S, Kim H, Yang DH, Kim Y-H, Kyung YS, et al. Three-dimensional printing: basic principles and applications in medicine and radiology. Korean J Radiol. 2016;17(2):182–97. https://doi.org/10.3348/kjr.2016.17.2.182.
Katatny IE, Masood SH, Morsi YS. Evaluation and validation of the shape accuracy of FDM fabricated medical models. Adv Mater Res. 2009;83–86:275–80.
Hsu C, Lin C, Fan C, Chiang N Y, Tsai C W, Chang C M, et al. Shape accuracy of an acrylonitrile butadiene styrene canine tibia model fabricated using fused deposition modelling and the effects of hydrogen peroxide gas plasma sterilisation. BMC Vet Res. 2020:1–18. https://doi.org/10.21203/rs.3.rs-35517/v1.
Neches RY, Flynn KJ, Zaman L, Tung E, Pudlo N. On the intrinsic sterility of 3D printing. PeerJ. 2016;4(12):e2661. https://doi.org/10.7717/peerj.2661.
Marei HF, Alshaia A, Alarifi S, Almasoud N, Abdelhady A. Effect of steam heat sterilization on the accuracy of 3D printed surgical guides. Implant Dent. 2019;28(4):372–7. https://doi.org/10.1097/ID.0000000000000908.
Oth O, Dauchot C, Orellana M, Glineur R. How to sterilize 3D printed objects for surgical use? An evaluation of the volumetric deformation of 3D-printed Genioplasty guide in PLA and PETG after sterilization by low-temperature hydrogen peroxide gas plasma. Open Dent J. 2019;13(1):410–7. https://doi.org/10.2174/1874210601913010410.
Chen JV, Tanaka KS, Dang ABC, Dang A. Identifying a commercially-available 3D printing process that minimizes model distortion after annealing and autoclaving and the effect of steam sterilization on mechanical strength. 3D Print Med. 2020;6(1):9.
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. https://doi.org/10.2174/1874210601812010072.
Kuczko W, Wichniarek R, Górski F, Banaszewski J. Influence of sterilization of a product manufactured using FDM technology on its dimensional accuracy. Adv Sci Technol Res J. 2018;12(1):74–9. https://doi.org/10.12913/22998624/80849.