3D printing in medicine最新文献

{"title":"Computer-aided design and 3D printing for a stable construction of segmental bone defect model in Beagles: a short term observation.","authors":"Kai Cheng, Haotian Zhu, Yuanhao Peng, Xinghua Wen, Huanwen Ding","doi":"10.1186/s41205-024-00217-y","DOIUrl":"10.1186/s41205-024-00217-y","url":null,"abstract":"<p><strong>Objective: </strong>Segmental bone defect animal studies require stable fixation which is a continuous experimental challenge. Large animal models are comparable to the human bone, but with obvious drawbacks of housing and costs. Our study aims to utilize CAD and 3D printing in the construction of a stable and reproducible segmental bone defect animal mode.</p><p><strong>Methods: </strong>CAD-aided 3D printed surgical instruments were incorporated into the construction of the animal model through preoperative surgical emulation. 20 3D printed femurs were divided into either experimental group using 3D surgical instruments or control group. In Vitro surgical time and accuracy of fixation were analysed and compared between the two groups. A mature surgical plan using the surgical instruments was then utilized in the construction of 3 segmental bone defect Beagle models in vivo. The Beagles were postoperatively assessed through limb function and imaging at 1, 2 and 3 months postoperatively.</p><p><strong>Results: </strong>In vitro experiments showed a significant reduction in surgical time from 40.6 ± 14.1 (23-68 min) to 26 ± 4.6 (19-36 min) (n = 10, p < 0.05) and the accuracy of intramedullary fixation placement increased from 71.6 ± 23.6 (33.3-100) % to 98.3 ± 5.37 (83-100) %, (n = 30, p < 0.05) with the use of CAD and 3D printed instruments. All Beagles were load-bearing within 1 week, and postoperative radiographs showed no evidence of implant failure.</p><p><strong>Conclusion: </strong>Incorporation of CAD and 3D printing significantly increases stability, while reducing the surgical time in the construction of the animal model, significantly affecting the success of the segmental bone defect model in Beagles.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"20"},"PeriodicalIF":3.2,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11197206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141447674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Desktop 3D printed anatomic models for minimally invasive direct coronary artery bypass.","authors":"Prashanth Ravi, Michael B Burch, Andreas A Giannopoulos, Isabella Liu, Shayne Kondor, Leonid L Chepelev, Tommaso H Danesi, Frank J Rybicki, Antonio Panza","doi":"10.1186/s41205-024-00222-1","DOIUrl":"10.1186/s41205-024-00222-1","url":null,"abstract":"<p><strong>Background: </strong>Three-dimensional (3D) printing technology has impacted many clinical applications across medicine. However, 3D printing for Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) has not yet been reported in the peer-reviewed literature. The current observational cohort study aimed to evaluate the impact of half scaled (50% scale) 3D printed (3DP) anatomic models in the pre-procedural planning of MIDCAB.</p><p><strong>Methods: </strong>Retrospective analysis included 12 patients who underwent MIDCAB using 50% scale 3D printing between March and July 2020 (10 males, 2 females). Distances measured from CT scans and 3DP anatomic models were correlated with Operating Room (OR) measurements. The measurements were compared statistically using Tukey's test. The correspondence between the predicted (3DP & CT) and observed best InterCostal Space (ICS) in the OR was recorded. Likert surveys from the 3D printing registry were provided to the surgeon to assess the utility of the model. The OR time saved by planning the procedure using 3DP anatomic models was estimated subjectively by the cardiothoracic surgeon.</p><p><strong>Results: </strong>All 12 patients were successfully grafted. The 3DP model predicted the optimal ICS in all cases (100%). The distances measured on the 3DP model corresponded well to the distances measured in the OR. The measurements were significantly different between the CT and 3DP (p < 0.05) as well as CT and OR (p < 0.05) groups, but not between the 3DP and OR group. The Likert responses suggested high clinical utility of 3D printing. The mean subjectively estimated OR time saved was 40 min.</p><p><strong>Conclusion: </strong>The 50% scaled 3DP anatomic models demonstrated high utility for MIDCAB and saved OR time while being resource efficient. The subjective benefits over routine care that used 3D visualization for surgical planning warrants further investigation.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"19"},"PeriodicalIF":0.0,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11167900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141307451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enabling the design of surgical instruments for under-resourced patients through metal additive manufacturing: ulnar shortening osteotomy as an example.","authors":"Kuan-Lin Chen, Cheng-Yu Yin, Hui-Kuang Huang, Yi-Chao Huang, Jung-Pan Wang","doi":"10.1186/s41205-024-00220-3","DOIUrl":"10.1186/s41205-024-00220-3","url":null,"abstract":"<p><strong>Background: </strong>Ulnar shortening osteotomy (USO) has demonstrated good outcomes for patients with ulnar impaction syndrome. To minimize complications such as non-union, precise osteotomy and firm fixation are warranted. Despite various ulnar shortening systems have been developed, current technology does not meet all needs. A considerable portion of patients could not afford those designated USO systems. To tackle this challenge, our team reported successful results in standardized free-hand predrilled USO technique. However, it is still technical demanding and requires sufficient experience and confidence to excel. Therefore, our team designed an ulnar shortening system based on our free-hand technique principle, using metal additive manufacturing technology. The goal of this study is to describe the development process and report the performance of the system.</p><p><strong>Methods: </strong>Utilizing metal additive manufacturing technology, our team developed an ulnar shortening system that requires minimal exposure, facilitates precise cutting, and allows for the easy placement of a 3.5 mm dynamic compression plate, available to patients at zero out-of-pocket cost. For performance testing, two surgeons with different levels of experience in ulnar shortening procedures were included: one fellow-trained hand and wrist surgeon and one senior resident. They performed ulnar shortening osteotomy (USO) using both the free-hand technique and the USO system-assisted technique on ulna sawbones, repeating each method three times. The recorded parameters included time-to-complete-osteotomy, total procedure time, chip diameter, shortening length, maximum residual gap, and deviation angle.</p><p><strong>Results: </strong>For the hand and wrist fellow, with the USO system, the time-to-complete osteotomy was significantly reduced. (468.7 ± 63.6 to 260.0 ± 5 s, p < 0.05). Despite the preop goal was shortening 3 mm, the average shortening length was significantly larger in the free-hand group (5 ± 0.1; 3.2 ± 0.2 mm, p < 0.05). Both maximum residual gap and deviation angle reported no statistical difference between the two techniques for the hand surgeon. As for the senior resident, the maximum residual gap was significantly reduced, using the USO system (2.9 ± 0.8; 0.4 ± 0.4 mm, p = 0.02). Between two surgeons, significant larger maximum residual gap and deviation angle were noted on the senior resident doctor, in the free-hand technique group, but not in the USO system group.</p><p><strong>Conclusion: </strong>The developed USO system may serve as a valuable tool, aiding in reliable and precise cutting as well as fixation for patients undergoing ulnar shortening osteotomy with a 3.5 mm dynamic compression plate, even for less experienced surgeons. The entire process, from concept generation and sketching to creating the CAD file and final production, serves as a translatable reference for other surgical scenarios.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"18"},"PeriodicalIF":0.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11141050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tablet-based Augmented reality and 3D printed templates in fully guided Microtia Reconstruction: a clinical workflow.","authors":"Alberto Díez-Montiel, Alicia Pose-Díez-de-la-Lastra, Alba González-Álvarez, José I Salmerón, Javier Pascau, Santiago Ochandiano","doi":"10.1186/s41205-024-00213-2","DOIUrl":"10.1186/s41205-024-00213-2","url":null,"abstract":"<p><strong>Background: </strong>Microtia is a congenital malformation of the auricle that affects approximately 4 of every 10,000 live newborns. Radiographic film paper is traditionally employed to bidimensionally trace the structures of the contralateral healthy ear in a quasi-artistic manner. Anatomical points provide linear and angular measurements. However, this technique proves time-consuming, subjectivity-rich, and greatly dependent on surgeon expertise. Hence, it's susceptible to shape errors and misplacement.</p><p><strong>Methods: </strong>We present an innovative clinical workflow that combines 3D printing and augmented reality (AR) to increase objectivity and reproducibility of these procedures. Specifically, we introduce patient-specific 3D cutting templates and remodeling molds to carve and construct the cartilaginous framework that will conform the new ear. Moreover, we developed an in-house AR application compatible with any commercial Android tablet. It precisely guides the positioning of the new ear during surgery, ensuring symmetrical alignment with the healthy one and avoiding time-consuming intraoperative linear or angular measurements. Our solution was evaluated in one case, first with controlled experiments in a simulation scenario and finally during surgery.</p><p><strong>Results: </strong>Overall, the ears placed in the simulation scenario had a mean absolute deviation of 2.2 ± 1.7 mm with respect to the reference plan. During the surgical intervention, the reconstructed ear was 3.1 mm longer and 1.3 mm wider with respect to the ideal plan and had a positioning error of 2.7 ± 2.4 mm relative to the contralateral side. Note that in this case, additional morphometric variations were induced from inflammation and other issues intended to be addressed in a subsequent stage of surgery, which are independent of our proposed solution.</p><p><strong>Conclusions: </strong>In this work we propose an innovative workflow that combines 3D printing and AR to improve ear reconstruction and positioning in microtia correction procedures. Our implementation in the surgical workflow showed good accuracy, empowering surgeons to attain consistent and objective outcomes.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"17"},"PeriodicalIF":0.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11140883/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing a production workflow for 3D-printed temporal bone surgical simulators.","authors":"Andre Jing Yuen Ang, Shu Ping Chee, Joyce Zhi En Tang, Ching Yee Chan, Vanessa Yee Jueen Tan, Jordan Adele Lee, Thomas Schrepfer, Noor Mohamed Nisar Ahamed, Mark Bangwei Tan","doi":"10.1186/s41205-024-00218-x","DOIUrl":"10.1186/s41205-024-00218-x","url":null,"abstract":"<p><strong>Introduction: </strong>3D-printed temporal bone models enable the training and rehearsal of complex otological procedures. To date, there has been no consolidation of the literature regarding the developmental process of 3D-printed temporal bone models. A brief review of the current literature shows that many of the key surgical landmarks of the temporal bone are poorly represented in models. This study aims to propose a novel design and production workflow to produce high-fidelity 3D-printed temporal bone models for surgical simulation.</p><p><strong>Methods: </strong>Developmental phases for data extraction, 3D segmentation and Computer Aided Design (CAD), and fabrication are outlined. The design and fabrication considerations for key anatomical regions, such as the mastoid air cells and course of the facial nerve, are expounded on with the associated strategy and design methods employed. To validate the model, radiological measurements were compared and a senior otolaryngologist performed various surgical procedures on the model.</p><p><strong>Results: </strong>Measurements between the original scans and scans of the model demonstrate sub-millimetre accuracy of the model. Assessment by the senior otologist found that the model was satisfactory in simulating multiple surgical procedures.</p><p><strong>Conclusion: </strong>This study offers a systematic method for creating accurate 3D-printed temporal bone models for surgical training. Results show high accuracy and effectiveness in simulating surgical procedures, promising improved training and patient outcomes.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"16"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11138071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141176948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fabricating patient-specific 3D printed drill guides to treat femoral head avascular necrosis.","authors":"Cameron Bell, Alborz Feizi, Gregory R Roytman, Alim F Ramji, Steven M Tommasini, Daniel H Wiznia","doi":"10.1186/s41205-024-00208-z","DOIUrl":"10.1186/s41205-024-00208-z","url":null,"abstract":"<p><strong>Background: </strong>Femoral head avascular necrosis (AVN), or death of femoral head tissue due to a lack of blood supply, is a leading cause of total hip replacement for non-geriatric patients. Core decompression (CD) is an effective treatment to re-establish blood flow for patients with AVN. Techniques aimed at improving its efficacy are an area of active research. We propose the use of 3D printed drill guides to accurately guide therapeutic devices for CD.</p><p><strong>Methods: </strong>Using femur sawbones, image processing software, and 3D modeling software, we created a custom-built device with pre-determined drill trajectories and tested the feasibility of the 3D printed drill guides for CD. A fellowship trained orthopedic surgeon used the drill guide to position an 8 ga, 230 mm long decompression device in the three synthetic femurs. CT scans were taken of the sawbones with the drill guide and decompression device. CT scans were processed in the 3D modeling software. Descriptive statistics measuring the angular and needle-tip deviation were compared to the original virtually planned model.</p><p><strong>Results: </strong>Compared to the original 3D model, the trials had a mean displacement of 1.440 ± 1.03 mm and a mean angle deviation of 1.093 ± 0.749º.</p><p><strong>Conclusions: </strong>The drill guides were demonstrated to accurately guide the decompression device along its predetermined drill trajectory. Accuracy was assessed by comparing values to literature-reported values and considered AVN lesion size. This study demonstrates the potential use of 3D printing technology to improve the efficacy of CD techniques.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"10"},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10986134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality assurance of 3D-printed patient specific anatomical models: a systematic review.","authors":"Martin Schulze, Lukas Juergensen, Robert Rischen, Max Toennemann, Gregor Reischle, Jan Puetzler, Georg Gosheger, Julian Hasselmann","doi":"10.1186/s41205-024-00210-5","DOIUrl":"10.1186/s41205-024-00210-5","url":null,"abstract":"<p><strong>Background: </strong>The responsible use of 3D-printing in medicine includes a context-based quality assurance. Considerable literature has been published in this field, yet the quality of assessment varies widely. The limited discriminatory power of some assessment methods challenges the comparison of results. The total error for patient specific anatomical models comprises relevant partial errors of the production process: segmentation error (SegE), digital editing error (DEE), printing error (PrE). The present review provides an overview to improve the general understanding of the process specific errors, quantitative analysis, and standardized terminology.</p><p><strong>Methods: </strong>This review focuses on literature on quality assurance of patient-specific anatomical models in terms of geometric accuracy published before December 4th, 2022 (n = 139). In an attempt to organize the literature, the publications are assigned to comparable categories and the absolute values of the maximum mean deviation (AMMD) per publication are determined therein.</p><p><strong>Results: </strong>The three major examined types of original structures are teeth or jaw (n = 52), skull bones without jaw (n = 17) and heart with coronary arteries (n = 16). VPP (vat photopolymerization) is the most frequently employed basic 3D-printing technology (n = 112 experiments). The median values of AMMD (AMMD: The metric AMMD is defined as the largest linear deviation, based on an average value from at least two individual measurements.) are 0.8 mm for the SegE, 0.26 mm for the PrE and 0.825 mm for the total error. No average values are found for the DEE.</p><p><strong>Conclusion: </strong>The total error is not significantly higher than the partial errors which may compensate each other. Consequently SegE, DEE and PrE should be analyzed individually to describe the result quality as their sum according to rules of error propagation. Current methods for quality assurance of the segmentation are often either realistic and accurate or resource efficient. Future research should focus on implementing models for cost effective evaluations with high accuracy and realism. Our system of categorization may be enhancing the understanding of the overall process and a valuable contribution to the structural design and reporting of future experiments. It can be used to educate specialists for risk assessment and process validation within the additive manufacturing industry.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"9"},"PeriodicalIF":0.0,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10967057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140308110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The clinical value of preoperative 3D planning and 3D surgical guides for Imhäuser osteotomy in slipped capital femoral epipysis: a retrospective study.","authors":"Vera Lagerburg, Michelle van den Boorn, Sigrid Vorrink, Ihsane Amajjar, Melinda M E H Witbreuk","doi":"10.1186/s41205-024-00205-2","DOIUrl":"10.1186/s41205-024-00205-2","url":null,"abstract":"<p><strong>Background: </strong>Accurate repositioning of the femoral head in patients with Slipped Capital Femoral Epiphysis (SCFE) undergoing Imhäuser osteotomy is very challenging. The objective of this study is to determine if preoperative 3D planning and a 3D-printed surgical guide improve the accuracy of the placement of the femoral head.</p><p><strong>Methods: </strong>This retrospective study compared outcome parameters of patients who underwent a classic Imhäuser osteotomy from 2009 to 2013 with those who underwent an Imhäuser osteotomy using 3D preoperative planning and 3D-printed surgical guides from 2014 to 2021. The primary endpoint was improvement in Range of Motion (ROM) of the hip. Secondary outcomes were radiographic improvement (Southwick angle), patient-reported clinical outcomes regarding hip and psychosocial complaints assessed with two questionnaires and duration of surgery.</p><p><strong>Results: </strong>In the 14 patients of the 3D group radiographic improvement was slightly greater and duration of surgery was slightly shorter than in the 7 patients of the classis Imhäuser group. No difference was found in the ROM, and patient reported clinical outcomes were slightly less favourable.</p><p><strong>Conclusions: </strong>Surprisingly we didn't find a significant difference between the two groups. Further research on the use of 3D planning an 3D-printed surgical guides is needed.</p><p><strong>Trial registration: </strong>Approval for this study was obtained of the local ethics committees of both hospitals.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10908070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139998352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The feasibility of a novel 3D-Printed patient specific cutting guide for extended trochanteric osteotomies.","authors":"Reza Bergemann, Gregory R Roytman, Lidia Ani, Alim F Ramji, Michael P Leslie, Steven M Tommasini, Daniel H Wiznia","doi":"10.1186/s41205-024-00204-3","DOIUrl":"10.1186/s41205-024-00204-3","url":null,"abstract":"<p><strong>Background: </strong>The extended trochanteric osteotomy (ETO) is a surgical technique utilized to expose the intramedullary canal of the proximal femur, protect the soft tissues and promote reliable healing. However, imprecise execution of the osteotomy can lead to fracture, soft tissue injury, non-union, and unnecessary morbidity. We developed a technique to create patient specific, 3D-printed cutting guides to aid in accurate positioning of the ETO and improve osteotomy quality and outcomes.</p><p><strong>Methods: </strong>Patient specific cutting guides were created based on CT scans using Synopysis Simpleware ScanIP and Solidworks. Custom 3D printed cutting guides were tested on synthetic femurs with foam cortical shells and on cadaveric femurs. To confirm accuracy of the osteotomies, dimensions of the performed osteotomies were compared to the virtually planned osteotomies.</p><p><strong>Results: </strong>Use of the patient specific ETO cutting guides resulted in successful osteotomies, exposing the femoral canal and the femoral stem both in synthetic sawbone and cadaveric testing. In cadaveric testing, the guides allowed for osteotomies without fracture and cuts made using the guide were accurate within 6 percent error from the virtually planned osteotomy.</p><p><strong>Conclusion: </strong>The 3D-printed patient specific cutting guides used to aid in ETOs proved to be accurate. Through the iterative development of cutting guides, we found that a simple design was key to a reliable and accurate guide. While future clinical trials in human subjects are needed, we believe our custom 3D printed cutting guide design to be effective at aiding in performing ETOs for revision total hip arthroplasty surgeries.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10905807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139998353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices.","authors":"Randal Eveland, Kathleen Antloga, Ashley Meyer, Lori Tuscano","doi":"10.1186/s41205-024-00206-1","DOIUrl":"10.1186/s41205-024-00206-1","url":null,"abstract":"<p><strong>Background: </strong>Low temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility.</p><p><strong>Materials & methods: </strong>Test articles were printed at Formlabs with BioMed Clear™ and BioMed Amber™, and at Stratasys with MED610™, MED615™ and MED620™. Sterilization, biocompatibility and material compatibility studies with 3D printed materials were conducted after VH2O2 sterilization in V-PRO™ Sterilizers. The overkill method was used to evaluate sterilization in a ½ cycle. Biocompatibility testing evaluated the processed materials as limited contact (< 24-hours) surface or externally communicating devices. Material compatibility after VH2O2 sterilization (material strength and dimensionality) was evaluated via ASTM methods and dimensional analysis.</p><p><strong>Results: </strong>3D printed devices, within a specific design window, were sterile after VH2O2 ½ cycles. After multiple cycle exposure, the materials were not cytotoxic, not sensitizing, not an irritant, not a systemic toxin, not pyrogenic and were hemo-compatible. Material compatibility via ASTM testing and dimensionality evaluations did not indicate any significant changes to the 3D printed materials after VH2O2 sterilization.</p><p><strong>Conclusion: </strong>Low temperature vaporized hydrogen peroxide sterilization is demonstrated as a suitable method to sterilize 3D printed devices. The results are a subset of the data used in a regulatory submission with the US FDA to support claims for sterilization of 3D printed devices with specified materials, printers, and device design ¹.</p>","PeriodicalId":72036,"journal":{"name":"3D printing in medicine","volume":"10 1","pages":"6"},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10900786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139984649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}