Cumulative Inaccuracies in Implementation of Additive Manufacturing Through Medical Imaging, 3D Thresholding, and 3D Modeling: A Case Study for an End-Use Implant

In craniomaxillofacial surgical procedures, an emerging practice adopts the preoperative virtual planning that uses medical imaging (computed tomography), 3D thresholding (segmentation), 3D modeling (digital design), and additive manufacturing (3D printing) for the procurement of an end-use implant. The objective of this case study was to evaluate the cumulative spatial inaccuracies arising from each step of the process chain when various computed tomography protocols and thresholding values were independently changed. A custom-made quality assurance instrument (Phantom) was used to evaluate the medical imaging error. A sus domesticus (domestic pig) head was analyzed to determine the 3D thresholding error. The 3D modeling error was estimated from the computer-aided design software. Finally, the end-use implant was used to evaluate the additive manufacturing error. The results were verified using accurate measurement instruments and techniques. A worst-case cumulative error of 1.7 mm (3.0%) was estimated for one boundary condition and 2.3 mm (4.1%) for two boundary conditions considering the maximum length (56.9 mm) of the end-use implant. Uncertainty from the clinical imaging to the end-use implant was 0.8 mm (1.4%). This study helps practitioners establish and corroborate surgical practices that are within the bounds of an appropriate accuracy for clinical treatment and restoration.

[1]  Timothy Douglas,et al.  Rapid prototyping: porous titanium alloy scaffolds produced by selective laser melting for bone tissue engineering. , 2009, Tissue engineering. Part C, Methods.

[2]  A. Farman,et al.  Clinical applications of cone-beam computed tomography in dental practice. , 2006, Journal.

[3]  D. Silva,et al.  Dimensional error of selective laser sintering, three-dimensional printing and PolyJet models in the reproduction of mandibular anatomy. , 2009, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[4]  E. Hannen,et al.  Recreating the original contour in tumor deformed mandibles for plate adapting. , 2006, International journal of oral and maxillofacial surgery.

[5]  P. Kujala,et al.  Miniature reproduction of raking tests on marine structure: Similarity technique and experiment , 2020, Engineering Structures.

[6]  J. J. Aguilar,et al.  Stereo vision for 3D measurement: accuracy analysis, calibration and industrial applications , 1996 .

[7]  T. L. Yang,et al.  Anisotropic response of Ti-6Al-4V alloy fabricated by 3D printing selective laser melting , 2017 .

[8]  E LorensenWilliam,et al.  Marching cubes: A high resolution 3D surface construction algorithm , 1987 .

[9]  Ming-Wei Wu,et al.  Anisotropy in the impact toughness of selective laser melted Ti–6Al–4V alloy , 2016 .

[10]  Jerzy A. Sladek,et al.  Coordinate Metrology: Accuracy of Systems and Measurements , 2015 .

[11]  Risto Kontio,et al.  Rapid prototyped patient specific guiding implants in critical mandibular reconstruction. , 2017, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[12]  Tomohiro Yamada,et al.  Custom-made titanium devices as membranes for bone augmentation in implant treatment: Modeling accuracy of titanium products constructed with selective laser melting. , 2015, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[13]  Pablo Irarrazaval,et al.  Quantitative assessments of geometric errors for rapid prototyping in medical applications , 2012 .

[14]  Pablo Irarrazaval,et al.  Sensitivity analysis of geometric errors in additive manufacturing medical models. , 2015, Medical engineering & physics.

[15]  Daniel Danielsson,et al.  Rapid prototyped patient specific implants for reconstruction of orbital wall defects. , 2014, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[16]  Dimitrios Mitsouras,et al.  Measuring and Establishing the Accuracy and Reproducibility of 3D Printed Medical Models. , 2017, Radiographics : a review publication of the Radiological Society of North America, Inc.

[17]  Jorge Vicente Lopes da Silva,et al.  Dimensional error in selective laser sintering and 3D-printing of models for craniomaxillary anatomy reconstruction. , 2008, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[18]  M. Figliuzzi,et al.  A novel root analogue dental implant using CT scan and CAD/CAM: selective laser melting technology. , 2012, International journal of oral and maxillofacial surgery.

[19]  R. Nowotny,et al.  Production of phantom materials using polymer powder sintering under vacuum. , 2002, Physics in medicine and biology.

[20]  Maureen van Eijnatten,et al.  The impact of manual threshold selection in medical additive manufacturing , 2016, International Journal of Computer Assisted Radiology and Surgery.

[21]  R. Jacobs,et al.  A comparative evaluation of Cone Beam Computed Tomography (CBCT) and Multi-Slice CT (MSCT). Part II: On 3D model accuracy. , 2010, European journal of radiology.

[22]  A. Mäkitie,et al.  Inaccuracies in additive manufactured medical skull models caused by the DICOM to STL conversion process. , 2014, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[23]  Mika Salmi,et al.  Implementation of Industrial Additive Manufacturing: Intelligent Implants and Drug Delivery Systems , 2018, Journal of functional biomaterials.

[24]  Ludomir Stefańczyk,et al.  Custom implant design and surgical pre-planning using rapid prototyping and anatomical models for the repair of orbital floor fractures , 2009 .

[25]  S Sindet-Pedersen,et al.  A comparison of three-dimensional computed tomography scans and stereolithographic models for evaluation of craniofacial anomalies. , 1996, Journal of oral and maxillofacial surgery.

[26]  Daniel Wismeijer,et al.  The accuracy of static computer‐aided implant surgery: A systematic review and meta‐analysis , 2018, Clinical oral implants research.

[27]  Reinhilde Jacobs,et al.  A comparative evaluation of Cone Beam Computed Tomography (CBCT) and Multi-Slice CT (MSCT) Part I. On subjective image quality. , 2010, European journal of radiology.

[28]  Jean-Pierre Kruth,et al.  Material incress manufacturing by rapid prototyping techniques , 1991 .

[29]  Michael J Miller,et al.  The Accuracy of Stereolithography in Planning Craniofacial Bone Replacement , 2003, The Journal of craniofacial surgery.

[30]  Lewis Mullen,et al.  Selective Laser Melting: a regular unit cell approach for the manufacture of porous, titanium, bone in-growth constructs, suitable for orthopedic applications. , 2009, Journal of biomedical materials research. Part B, Applied biomaterials.

[31]  Leonardo Ciocca,et al.  Accuracy of fibular sectioning and insertion into a rapid-prototyped bone plate, for mandibular reconstruction using CAD-CAM technology. , 2015, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[32]  Chi Mao,et al.  Applying Computer Techniques in Maxillofacial Reconstruction Using a Fibula Flap: A Messenger and an Evaluation Method , 2009, The Journal of craniofacial surgery.

[33]  Marcos Salganicoff,et al.  Accuracy of automated volumetry of pulmonary nodules across different multislice CT scanners , 2007, European Radiology.

[34]  J. Y. Choi,et al.  Analysis of errors in medical rapid prototyping models. , 2002, International journal of oral and maxillofacial surgery.

[35]  Bin Bo,et al.  Accurate reconstruction of discontinuous mandible using a reverse engineering/computer-aided design/rapid prototyping technique: a preliminary clinical study. , 2010, Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons.

[36]  Shayne Kondor,et al.  Accuracy of rapid prototype models for head and neck reconstruction. , 2011, The Journal of prosthetic dentistry.

[37]  Georges M. Fadel,et al.  Accuracy issues in CAD to RP translations , 1996 .

[38]  S. Standard GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT , 2006 .

[39]  T. Bardyn,et al.  A new method for computer-aided operation planning for extensive mandibular reconstruction. , 2006, Plastic and Reconstructive Surgery.

[40]  Kazuyuki Araki,et al.  Image quality assessment of three cone beam CT machines using the SEDENTEXCT CT phantom. , 2013, Dento maxillo facial radiology.

[41]  H Eufinger,et al.  Individual prostheses and resection templates for mandibular resection and reconstruction. , 1997, The British journal of oral & maxillofacial surgery.

[42]  P.K Sahoo,et al.  A survey of thresholding techniques , 1988, Comput. Vis. Graph. Image Process..

[43]  Jonas Andersson,et al.  Quality control in cone-beam computed tomography (CBCT) : EFOMP-ESTRO-IAEA protocol , 2017 .

[44]  J. Posnick,et al.  Craniofacial skeletal measurements based on computed tomography: Part I. Accuracy and reproducibility. , 1992, The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association.

[45]  Jacob Sosna,et al.  Clinical applications of physical 3D models derived from MDCT data and created by rapid prototyping. , 2011, AJR. American journal of roentgenology.

[46]  David Z. Zhang,et al.  Additive manufacturing: A framework for implementation , 2014 .

[47]  Mika Salmi,et al.  Accuracy of medical models made by additive manufacturing (rapid manufacturing). , 2013, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[48]  A. Wennerberg,et al.  Geometrical accuracy of metallic objects produced with additive or subtractive manufacturing: A comparative in vitro study. , 2018, Dental materials : official publication of the Academy of Dental Materials.

[49]  Adel Abou-ElFetouh,et al.  Computer‐guided rapid‐prototyped templates for segmental mandibular osteotomies: a preliminary report , 2011, The international journal of medical robotics + computer assisted surgery : MRCAS.

[50]  R. van Noort,et al.  Direct Metal Laser Sintering Titanium Dental Implants: A Review of the Current Literature , 2014, International journal of biomaterials.

[51]  Mika Salmi,et al.  A Novel Classification and Online Platform for Planning and Documentation of Medical Applications of Additive Manufacturing , 2014, Surgical innovation.

[52]  Alberto Torresin,et al.  Quality control in cone-beam computed tomography (CBCT) EFOMP-ESTRO-IAEA protocol (summary report). , 2017, Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics.

[53]  Michael J Yaszemski,et al.  Poly(propylene fumarate) bone tissue engineering scaffold fabrication using stereolithography: effects of resin formulations and laser parameters. , 2007, Biomacromolecules.

[54]  P. Major,et al.  Effect of object location on the density measurement and Hounsfield conversion in a NewTom 3G cone beam computed tomography unit. , 2008, Dento maxillo facial radiology.

[55]  Thomas Vietor,et al.  Methods and tools for identifying and leveraging additive manufacturing design potentials , 2018 .

[56]  F. Lobbezoo,et al.  Accuracy of MDCT and CBCT in three-dimensional evaluation of the oropharynx morphology , 2018, European journal of orthodontics.

[57]  P W Major,et al.  Density conversion factor determined using a cone-beam computed tomography unit NewTom QR-DVT 9000. , 2006, Dento maxillo facial radiology.

[58]  H. Baltas,et al.  Measurement of attenuation coefficients for bone, muscle, fat and water at 140, 364 and 662 keV γ-ray energies , 2006 .

[59]  S. Laakso,et al.  Anisotropy of additively manufactured AlSi10Mg: threads and surface integrity , 2020, The International Journal of Advanced Manufacturing Technology.

[60]  Jos Vander Sloten,et al.  A classification of cranial implants based on the degree of difficulty in computer design and manufacture , 2008, The international journal of medical robotics + computer assisted surgery : MRCAS.

[61]  K. Varadi,et al.  Internal or in-scan validation: a method to assess CBCT and MSCT gray scales using a human cadaver. , 2014, Oral surgery, oral medicine, oral pathology and oral radiology.

[62]  J. Poukens,et al.  A treatment algorithm for patients with large skull bone defects and first results. , 2011, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[63]  R. Hague *,et al.  Material and design considerations for rapid manufacturing , 2004 .

[64]  Francesco Guido Mangano,et al.  Custom-made, root-analogue direct laser metal forming implant: a case report , 2012, Lasers in Medical Science.

[65]  C. Colin,et al.  As-Fabricated and Heat-Treated Microstructures of the Ti-6Al-4V Alloy Processed by Selective Laser Melting , 2011 .

[66]  Daniel Noyes,et al.  Envisioning e-logistics developments: Making spare parts in situ and on demand: State of the art and guidelines for future developments , 2006, Comput. Ind..

[67]  J Vander Sloten,et al.  Accuracy assessment of CT-based outer surface femur meshes , 2008, Computer aided surgery : official journal of the International Society for Computer Aided Surgery.

[68]  Sang-Hoon Kang,et al.  Accuracy Assessment of Image-Based Surface Meshing for Volumetric Computed Tomography Images in the Craniofacial Region , 2014, The Journal of craniofacial surgery.

[69]  I. Ono,et al.  Method for Preparing an Exact‐Size Model Using Helical Volume Scan Computed Tomography , 1994, Plastic and reconstructive surgery.

[70]  A. J. van der Veen,et al.  3D-printing zirconia implants; a dream or a reality? An in-vitro study evaluating the dimensional accuracy, surface topography and mechanical properties of printed zirconia implant and discs. , 2017, Journal of the mechanical behavior of biomedical materials.

[71]  Enrico Savio,et al.  Metrology of freeform shaped parts , 2007 .

[72]  A Piattelli,et al.  Direct laser metal sintering as a new approach to fabrication of an isoelastic functionally graded material for manufacture of porous titanium dental implants. , 2008, Dental materials : official publication of the Academy of Dental Materials.

[73]  William E. Lorensen,et al.  Marching cubes: A high resolution 3D surface construction algorithm , 1987, SIGGRAPH.

[74]  A. V. Grigoriev,et al.  Anisotropy of mechanical properties of products manufactured using selective laser melting of powdered materials , 2017, Russian Journal of Non-Ferrous Metals.

[75]  Mika Salmi,et al.  Medical applications of rapid prototyping - From applications to classification , 2009 .

[76]  Yosry Morsi,et al.  Error analysis of FDM fabricated medical replicas , 2010 .

[77]  H. Bosmans,et al.  Variability of dental cone beam CT grey values for density estimations. , 2013, The British journal of radiology.

[78]  F. Rybicki,et al.  Medical 3D Printing for the Radiologist. , 2015, Radiographics : a review publication of the Radiological Society of North America, Inc.

[79]  Jan Wolff,et al.  CT image segmentation methods for bone used in medical additive manufacturing. , 2018, Medical engineering & physics.

[80]  Anne Thilander-Klang,et al.  Evaluation of subjective image quality in relation to diagnostic task for cone beam computed tomography with different fields of view. , 2011, European journal of radiology.

[81]  A. Mäkitie,et al.  Main Clinical Use of Additive Manufacturing (Three-Dimensional Printing) in Finland Restricted to the Head and Neck Area in 2016–2017 , 2019, Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society.

[82]  Erik-Jan Rijkhorst,et al.  The accuracy of ultrashort echo time MRI sequences for medical additive manufacturing. , 2016, Dento maxillo facial radiology.

[83]  Mika Salmi,et al.  Patient‐specific reconstruction with 3D modeling and DMLS additive manufacturing , 2012 .

[84]  T M Barker,et al.  Accuracy of stereolithographic models of human anatomy. , 1994, Australasian radiology.

[85]  T. Johnson,et al.  Dual-energy CT: general principles. , 2012, AJR. American journal of roentgenology.

[86]  F. Piller,et al.  Economic implications of 3D printing: Market structure models in light of additive manufacturing revisited , 2015 .

[87]  Lin Naing,et al.  Dimensional Accuracy of the Skull Models Produced by Rapid Prototyping Technology Using Stereolithography Apparatus , 2006 .

[88]  M. von Walter,et al.  Structural, mechanical and in vitro characterization of individually structured Ti-6Al-4V produced by direct laser forming. , 2006, Biomaterials.

[89]  Antti Lassila,et al.  Design and performance of an advanced metrology building for MIKES , 2011 .

[90]  M. Salmi,et al.  Three-dimensional printed surgical templates for fresh cadaveric osteochondral allograft surgery with dimension verification by multivariate computed tomography analysis. , 2019, The Knee.

[91]  M V T Navarro,et al.  Development and implementation of a low-cost phantom for quality control in cone beam computed tomography. , 2013, Radiation protection dosimetry.

[92]  A. Piattelli,et al.  Influence of direct laser fabrication implant topography on type IV bone: a histomorphometric study in humans. , 2009, Journal of biomedical materials research. Part A.

[93]  Mohsen Attaran,et al.  The rise of 3-D printing: The advantages of additive manufacturing over traditional manufacturing , 2017 .