3D printing in medicine最新文献

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: Approval for this study was obtained of the local ethics committees of both hospitals.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: 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.

Materials & methods: 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.

Results: 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.

Conclusion: 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.

Background: Additively manufactured (AM) anatomical bone models are primarily utilized for training and preoperative planning purposes. As such, they must meet stringent requirements, with dimensional accuracy being of utmost importance. This study aimed to evaluate the precision and accuracy of anatomical bone models manufactured using three different AM technologies: digital light processing (DLP), fused deposition modeling (FDM), and PolyJetting (PJ), built in three different part orientations. Additionally, the study sought to assess surgeons' perceptions of how well these models mimic real bones in simulated osteosynthesis.

Methods: Computer-aided design (CAD) models of six human radii were generated from computed tomography (CT) imaging data. Anatomical models were then manufactured using the three aforementioned technologies and in three different part orientations. The surfaces of all models were 3D-scanned and compared with the original CAD models. Furthermore, an anatomical model of a proximal femur including a metastatic lesion was manufactured using the three technologies, followed by (mock) osteosynthesis performed by six surgeons on each type of model. The surgeons' perceptions of the quality and haptic properties of each model were assessed using a questionnaire.

Results: The mean dimensional deviations from the original CAD model ranged between 0.00 and 0.13 mm with maximal inaccuracies < 1 mm for all models. In surgical simulation, PJ models achieved the highest total score on a 5-point Likert scale ranging from 1 to 5 (with 1 and 5 representing the lowest and highest level of agreement, respectively), (3.74 ± 0.99) in the surgeons' perception assessment, followed by DLP (3.41 ± 0.99) and FDM (2.43 ± 1.02). Notably, FDM was perceived as unsuitable for surgical simulation, as the material melted during drilling and sawing.

Conclusions: In conclusion, the choice of technology and part orientation significantly influenced the accuracy and precision of additively manufactured bone models. However, all anatomical models showed satisfying accuracies and precisions, independent of the AM technology or part orientation. The anatomical and functional performance of FDM models was rated by surgeons as poor.

Modern additive manufacturing enables the simultaneous processing of different materials during the printing process. While multimaterial 3D printing allows greater freedom in part design, the prediction of the mix-material properties becomes challenging. One type of multimaterials are matrix-inclusion composites, where one material contains inclusions of another material. Aim of this study was to develop a method to predict the uniaxial Young's modulus and Poisson's ratio of material jetted matrix-inclusion composites by a combination of simulations and experimental data.Fifty samples from commercially available materials in their pure and matrix-inclusion mixed forms, with cubic inclusions, have been fabricated using material jetting and mechanically characterized by uniaxial tensile tests. Multiple simulation approaches have been assessed and compared to the measurement results in order to find and validate a method to predict the multimaterials' properties. Optical coherence tomography and microscopy was used to characterize the size and structure of the multimaterials, compared to the design.The materials exhibited Young's moduli in the range of 1.4 GPa to 2.5 GPa. The multimaterial mixtures were never as stiff as the weighted volume average of the primary materials (up to [Formula: see text] softer for 45% RGD8530-DM inclusions in VeroClear matrix). Experimental data could be predicted by finite element simulations by considering a non-ideal contact stiffness between matrix and inclusion ([Formula: see text] for RGD8530-DM, [Formula: see text] for RGD8430-DM), and geometries of the printed inclusions that deviated from the design (rounded edge radii of [Formula: see text]m). Not considering this would lead to a difference of the estimation result of up to [Formula: see text]MPa (44%), simulating an inclusion volume fraction of 45% RGD8530-DM.Prediction of matrix-inclusion composites fabricated by multimaterial jetting printing, is possible, however, requires a priori knowledge or additional measurements to characterize non-ideal contact stiffness between the components and effective printed geometries, precluding therefore a simple multimaterial modelling.

Background: The use of medical 3D printing (focusing on anatomical modeling) has continued to grow since the Radiological Society of North America's (RSNA) 3D Printing Special Interest Group (3DPSIG) released its initial guideline and appropriateness rating document in 2018. The 3DPSIG formed a focused writing group to provide updated appropriateness ratings for 3D printing anatomical models across a variety of congenital heart disease. Evidence-based- (where available) and expert-consensus-driven appropriateness ratings are provided for twenty-eight congenital heart lesion categories.

Methods: A structured literature search was conducted to identify all relevant articles using 3D printing technology associated with pediatric congenital heart disease indications. Each study was vetted by the authors and strength of evidence was assessed according to published appropriateness ratings.

Results: Evidence-based recommendations for when 3D printing is appropriate are provided for pediatric congenital heart lesions. Recommendations are provided in accordance with strength of evidence of publications corresponding to each cardiac clinical scenario combined with expert opinion from members of the 3DPSIG.

Conclusions: This consensus appropriateness ratings document, created by the members of the RSNA 3DPSIG, provides a reference for clinical standards of 3D printing for pediatric congenital heart disease clinical scenarios.