3D Printing in Medicine (eBook)

Frank J. Rybicki, MD, PhD, is Professor and Chair of Radiology at the University of Ottawa and The Ottawa Hospital. Dr. Rybicki introduced wide-area detector CT to radiology in 2007, focused on cardiac computed tomography. Dr. Rybicki was the founding and first Chairperson of the Radiological Society of North America Special Interest Group on 3D printing and is the Editor-in-Chief of 3D Printing in Medicine. Gerald T. Grant, DMD, MS, FACP received his D.M.D. degree from the University of Louisville, School of Dentistry in 1985 and his specialty training in Maxillofacial Prosthetics from the Naval Postgraduate Dental School, Bethesda, Maryland in 1999. He is a Diplomat of the American Board of Prosthodontics. Dr. Grant has over 15 years of experience in the use of digital design and 3D printing in customized medical and dental care in both research and application. He directed the development and was Service Chief of the 3D Medical Applications Center, Department of Radiology, at Walter Reed National Military Medical Center, one of the first and largest in-hospital services, providing medical models, surgical guides, and custom medical/dental devices world-wide to US military facilities for Wounded Warrior care. He is currently retired after 33 years from the United States Navy and is a Professor and Interim Chair of the Oral Health and Rehabilitation Department at the University of Louisville School of Dentistry where he has developed collaborative research teams with the Schools of Medicine, Engineering, and Dentistry for Advanced Digital Applications in the design and fabrication of medical devices for craniofacial reconstruction, dental restoration and rehabilitation, and recently in bio-printing/bio-fabrication.

Acknowledgment 5
Contents 6
1: Introduction 8
1.1 History of 3D Printing in Medicine 9
1.2 History of 3D Printing in the US Military Medical Community 9
1.3 Current 3D Printing 11
2: 3D Printing Technologies 12
2.1 Introduction 12
2.1.1 Communicating with a 3D Printer: The Standard Tessellation File Format and Beyond 13
2.1.2 3D Printing Technologies 16
2.1.2.1 Vat Photopolymerization 16
2.1.2.2 Material Jetting 20
2.1.2.3 Binder Jetting 22
2.1.2.4 Material Extrusion 24
2.1.2.5 Powder Bed Fusion 25
2.1.2.6 Other Technologies 26
2.1.3 3D Printer Resolution, Accuracy, and Reproducibility 27
2.2 3D Printing Materials 28
2.3 Conclusions 28
References 29
3: Post-processing of DICOM Images 30
3.1 Introduction 30
3.2 Image Segmentation 32
3.3 STL Generation 34
3.4 Computer-Aided Design Software 36
3.5 Model Refinement and CAD Design 36
3.6 Virtual Procedural Planning 37
3.7 Model Quality 38
3.8 Preparation for 3D Printing 38
3.9 Special Applications 39
3.10 Conclusions 40
References 40
4: Beginning and Developing a Radiology-Based In-Hospital 3D Printing Lab 42
References 47
5: Craniofacial Applications of 3D Printing 49
5.1 Craniofacial Imaging 49
5.2 Cranioplasty 50
5.3 Craniofacial Reconstruction 51
5.4 Dental Implant Guides 52
5.5 Maxillofacial Prosthetics 54
5.6 Other Craniofacial Applications 54
5.7 Conclusions 55
References 55
6: 3D Printing in Neurosurgery 57
6.1 Introduction 57
6.2 Neurosurgery 57
6.3 Cranial and Facial Implants 58
6.4 3D-Printed Models for Surgical Simulation and Training 59
6.5 Preoperative and Intraoperative Surgical Simulation 62
6.6 Assisting in the Consent Process 62
6.7 Drawbacks of 3D Printing 62
6.8 Conclusions 62
References 62
7: Cardiovascular 3D Printing 65
7.1 Introduction 65
7.2 Congenital Heart Disease (CHD) 66
7.2.1 Complex Pediatric and Adult Congenital Heart Diseases 66
7.3 Adult Heart Disease 67
7.3.1 Left Atrial Appendage Closure 67
7.3.2 Hypertrophic Obstructive Cardiomyopathy 67
7.3.3 Cardiac Tumors 67
7.3.4 Valve Disease 67
7.4 3D Printing for the Systemic Vessels 70
7.5 Conclusions 72
References 72
8: Musculoskeletal 3D Printing 76
References 87
9: 3D Printing and Patient-Matched Implants 90
9.1 Background 90
9.2 Terminology 91
9.3 Medical Imaging and Digital Design of Patient-Matched Implants 92
9.4 How 3D Printing Fits In 93
9.5 Patient-Matched Implant Examples 94
9.6 Conclusions 99
References 99
10: FDA Regulatory Pathways and Technical Considerations for the 3D Printing of Medical Models and Devices 101
10.1 Introduction 101
10.2 The FDA’s Role 101
10.3 Brief Overview of FDA Regulatory Pathways for Medical Devices 102
10.3.1 Resources 102
10.3.2 Classification 103
10.3.2.1 Class I 103
10.3.2.2 Class II: Premarket Notification [510(k)] 103
10.3.2.3 Class III: Premarket Approval (PMA) 104
10.3.3 Clinical Studies 104
10.3.4 Pre-Submission Meetings 105
10.3.5 Other Regulatory Pathways 105
10.3.5.1 Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) 105
10.3.5.2 De Novo 106
10.3.5.3 Combination Products 106
10.4 Regulatory Landscape for 3D-Printed Medical Devices 106
10.4.1 Medical Implants and Accessories 106
10.4.2 Surgical Visualization Models 107
10.4.3 Prosthetics and Quality of Life Accessories 107
10.5 Printing Materials 107
10.5.1 Characterization 107
10.5.2 Biological Suitability 108
10.6 The Design Process 109
10.6.1 Engineering Tools 109
10.6.1.1 Failure Mode Effects Analysis (FMEA) 110
10.6.1.2 User-Centric and Patient-­Centric Design 110
10.6.2 Patient-Matching Workflow 110
10.7 The Manufacturing Process 110
10.7.1 Software/Hardware Interactions 110
10.7.2 Building a Part 112
10.7.2.1 Part Orientation and Location in the Build Volume 112
10.7.2.2 Support Materials 112
10.7.2.3 Machine Parameters 112
10.7.2.4 Post-Processing 112
10.8 Verification and Process Validation 113
10.8.1 Quality Systems 113
10.8.2 Monitoring 113
10.8.3 Test Coupons 113
10.9 Conclusions 114
References 115
11: Quality and Safety of 3D-Printed Medical Models 116
11.1 Phantom-Based Quality Control 117
11.2 Mathematical Metrics of Quality Control 119
11.2.1 Model Surface Distances 120
11.2.2 Residual Volume 122
11.3 Self-Validating Models 125
11.4 “End-to-End” 3D Printing Quality Control 125
11.5 Conclusions 126
References 126
12: Virtual Reality 127
12.1 Introduction 127
12.2 History of Virtual Reality 128
12.2.1 Early Milestones 128
12.2.2 Alternative Technological Approaches 129
12.2.3 Historical Applications in Medicine 129
12.2.4 A Technology Outpaced by Vision 129
12.3 Modern Commercial Virtual Reality Technologies 130
12.3.1 Renewed Interest in VR 130
12.3.2 Mobile VR 130
12.3.3 Augmented Reality 131
12.4 Medical Virtual Reality and 3D Printing 132
12.5 Conclusions 134
References 134
Index 136