3D Printing at Hospitals and Medical Centers: A Practical Guide for Medical Professionals

Foreword to the Second Edition
Contents
1: Introduction to the Second Edition
	1.1	 Introduction
	1.2	 3D Printing is a Medical Procedure with Value
	1.3	 Patient Presentation
	1.4	 Medical Imaging
	1.5	 Requisition and Initial Consultation
	1.6	 Digital Planning, and Arriving at the Final Anatomic Representation (FAR)
	1.7	 The Computer Aided Design (CAD) “Superhighway”
	1.8	 Risk Assessment
	1.9	 Data Generation
	1.10	 Medical Value
	1.11	 Appropriate Clinical Scenario
	1.12	 Summary
	References
2: Image Processing, Including Software Considerations for Medical 3D Printing
	2.1	 Introduction
	2.2	 Image Segmentation
	2.3	 3D File Generation
	2.4	 Computer-Aided Design (CAD) Software
	2.5	 Model Refinement and CAD Design
	2.6	 Virtual Procedural Planning
	2.7	 Model Quality
	2.8	 Preparation for 3D Printing
	2.9	 Archiving 3D Printing Formats Using DICOM
	2.10	 Special Applications
	2.11	 Conclusion and Future Perspectives
	References
3: Pre-processing and Preparation of Medical 3D Printed Parts
	3.1	 Introduction
	3.2	 STL Generation
	3.3	 Orientation and Support Structures
	3.4	 Model Placement
		3.4.1	 Inverted Vat Polymerization
		3.4.2	 Material Jetting
	3.5	 Summary
	References
4: 3D Printing Technologies and Materials
	4.1	 Introduction
	4.2	 Communicating with a 3D Printer—Image Intensities in DICOM Files vs Printable Model File Formats
	4.3	 3D Printing Technologies
		4.3.1	 Vat Photopolymerization
		4.3.2	 Material Jetting
		4.3.3	 Binder Jetting
		4.3.4	 Material Extrusion
		4.3.5	 Powder Bed Fusion
		4.3.6	 Other Technologies
	4.4	 3D Printer Resolution, Accuracy, and Reproducibility
	4.5	 3D Printing Material Implications for Medical Applications
	4.6	 Biocompatible Materials and Sterilization
	4.7	 Radiographically Differentiable Materials
	4.8	 Summary
	References
5: Thoracic 3D Printing
	5.1	 Introduction
	5.2	 Lung Tumor Overview
	5.3	 Pancoast Tumor
	5.4	 Perihilar Tumor
		5.4.1	 Small Cell Lung Carcinoma
	5.5	 Pulmonary Nodule Resection
	5.6	 Laryngotracheal Stenosis
		5.6.1	 3D Printing in LTS
	5.7	 Chest Wall Reconstruction
	5.8	 Chest Wall Deformity Correction
	5.9	 Percutaneous Needle Biopsy of Lung Nodules
	5.10	 Esophageal Cancer
	5.11	 Mediastinal Masses
	5.12	 Bronchoscopy Training and Simulation
	5.13	 Surgical Techniques and Simulation
	5.14	 Patient Education
	5.15	 Conclusion
	References
6: Cardiac 3D Printing
	6.1	 Introduction
	6.2	 Imaging
		6.2.1	 Segmentation and Reconstruction
		6.2.2	 Blood Volume Versus Intracardiac Modeling
		6.2.3	 Artificial Intelligence (AI): Based Segmentation
	6.3	 Pathologies
		6.3.1	 Congenital Heart Disease (CHD)
		6.3.2	 Biventricular Evaluation
		6.3.3	 Adult Heart Disease
			6.3.3.1	 Left Atrial Appendage Closure
			6.3.3.2	 Hypertrophic Cardiomyopathy
			6.3.3.3	 Valve Disease
			6.3.3.4	 Coronary Artery Disease (CAD)
		6.3.4	 Mechanical Circulatory Support (MCS) Device Planning
		6.3.5	 Transplant Planning
	6.4	 Summary
	References
7: Musculoskeletal 3D Printing
	7.1	 Introduction
	7.2	 Image Acquisition
	7.3	 3D Printed Orthopedic Implants
	7.4	 3D Printed Arthroplasty Cutting Guides
	7.5	 3D Printed Arthroplasty Implants
	7.6	 3D Printing in Revision Arthroplasty Complicated by Bone Loss
	7.7	 3D Printing in Foot and Ankle Surgery
	7.8	 3D Printing in Orthotic and Prosthetics
	7.9	 3D Printing for Upper-Limb Surgery
	7.10	 3D Printing in Orthopedic Surgical Oncology
	7.11	 3D Printing in Pelvis and Acetabular Trauma Surgery
	7.12	 3D Printing in the Management of Extremity Fractures and Their Complications
	7.13	 Joint Preservation
	7.14	 3D Printing in Orthopedic Infections
	7.15	 3D Printing in Medical and Patient Education
	7.16	 Orthopedic Bioprinting
	7.17	 Summary
	References
8: 3D Printing in Oral and Maxillofacial Surgery
	8.1	 Introduction
	8.2	 Typical Personalized Surgery Workflow
		8.2.1	 Imaging and Clinical Needs Assessment
		8.2.2	 Data Preparation/Pre-Planning
		8.2.3	 Surgical Planning (or Guide/Implant Design)
		8.2.4	 Review/Approval
		8.2.5	 3D Printing
		8.2.6	 Surgery
	8.3	 Oral and Maxillofacial Surgical Applications
		8.3.1	 Dental Implants
		8.3.2	 Total TMJ Reconstruction/Replacement
		8.3.3	 Craniomaxillofacial Trauma
		8.3.4	 Orthognathic Surgery
		8.3.5	 Ablation and Reconstruction of Head and Neck Neoplasm
	8.4	 Conclusion
	References
9: Case Examples of Advanced 3D Printing in Hospitals and Medical Centers
	9.1	 Introduction
	9.2	 Summary
	References
10: 3D Printing and Digital Design for Maxillofacial Prosthetics
	10.1	 Introduction
	10.2	 Historical Overview
	10.3	 Terminology
	10.4	 The Digital Workflow
	10.5	 Acquisition
	10.6	 Design
	10.7	 Exploring Texture
	10.8	 Designing for Fit
	10.9	 Output “Fabrication”
	10.10	 Materials
	10.11	 Surgical Planning and Guides
	10.12	 Clinical Applications
		10.12.1 Ear
		10.12.2 Nose
		10.12.3 Eye
		10.12.4 Ocular
	10.13	 Intraoral Scanners
	10.14	 Other Devices
	10.15	 Utility and Efficiency: The Digital Workflow
	10.16	 Is 3D Printing of a Definitive Prosthesis a Viable Possibility?
	10.17	 Summary
	References
11: Patient-Specific Planning in Head and Neck Reconstruction Including Virtual Reality
	11.1	 Introduction
	11.2	 Evolution of Medical and Surgical Imaging
	11.3	 Features and Benefits of Computer Aided Design (CAD)
	11.4	 The Role of 3D Printing
	11.5	 Patient-Specific Solid Models
	11.6	 Cutting and Marking Guides
	11.7	 Positioning Guides and Occlusal Splints
	11.8	 Patient-Specific Implants
	11.9	 Specific Applications of CAD and 3D Printing: Surgical Planning
		11.9.1	 Orthognathic Surgery
		11.9.2	 Temporomandibular Joint Replacement
		11.9.3	 Midface/Zygomatic Osteotomy and Repositioning
		11.9.4	 Microsurgical Jaw Reconstruction
		11.9.5	 Osseointegrated Implant Placement
	11.10	 Disadvantages of Current Computer-Aided Surgery Techniques
	11.11	 Virtual Reality: Natural Evolution of Computer-Aided Visualization and Surgery
		11.11.1 Control Interface
		11.11.2 ImmersiveView—Building a Virtual-Reality Toolkit
		11.11.3 Applications in Maxillofacial Trauma
		11.11.4 Beyond Visualization
		11.11.5 Orthognathic Planning
		11.11.6 Osseointegrated Implant Planning
		11.11.7 Microvascular Facial Bone Reconstruction
	11.12	 Conclusions
	References
12: 3D Printing and Neurotechnology in Cranial Reconstruction
	12.1	 Introduction
	12.2	 Cranial Reconstruction
	12.3	 Feasibility of Implantable Devices
	12.4	 Implant Accommodation
	12.5	 Advanced Neurological Implant Manufacturing
	12.6	 Future Implications
	12.7	 Limitations
	12.8	 Conclusions
	References
13: 3D Printing in Neurosurgery and Neurovascular Intervention
	13.1	 Introduction
	13.2	 Cerebrovascular Disease
		13.2.1	 Intracranial Aneurysms
			13.2.1.1	 3D Printing for Intracranial Aneurysms
			13.2.1.2	 3D Printing for Arteriovenous Malformations
			13.2.1.3	 3D Printing of Dural Venous Sinuses and Cerebral Veins
	13.3	 Skull Base
		13.3.1	 Pituitary Gland
			13.3.1.1	 3D Printing for the Pituitary Gland
		13.3.2	 Meningiomas
			13.3.2.1	 3D Printing for Meningiomas
		13.3.3	 Craniopharyngioma
		13.3.4	 Vestibular Schwannoma
			13.3.4.1	 3D Printing for Vestibular Schwannoma
		13.3.5	 Chordoma
			13.3.5.1	 3D Printing for Clival Chordoma
		13.3.6	 Chiari Malformation
		13.3.7	 Esthesioneuroblastoma
		13.3.8	 Disorders of Cerebral Spinal Fluid
			13.3.8.1	 CSF Leak
				3D Printing of CSF Leak
			13.3.8.2	 CSF Obstruction
		13.3.9	 Temporal Bone
			13.3.9.1	 Ossicular Chain
			13.3.9.2	 Labyrinth
				Cochlea
				Semicircular Canals
			13.3.9.3	 Petrous Apex
		13.3.10	 Brain Tumors
			13.3.10.1	 Cranial Nerves
	13.4	 3D Printing in Pediatric Neurosurgery
		13.4.1	 3D Printing in Cerebrovascular Disorders
		13.4.2	 3D Printing in Craniomaxillofacial Deformities
		13.4.3	 3D Printing in Pediatric Brain Tumors
	References
14: Applications of 3D Printing in the Spine
	14.1	 Introduction
	14.2	 Factors Affecting Accuracy of Spine Models
	14.3	 Toward a Biomimetic Spine Model
	14.4	 Training and Education
	14.5	 Surgical Planning
	14.6	 Surgical Guides and Templates
	14.7	 Surgical Implants
	14.8	 Other Applications
	14.9	 Conclusion
	References
15: Applications of 3D Printing in the Abdomen and Pelvis
	15.1	 Introduction
	15.2	 3D Printing in Hepatobiliary Diseases
		15.2.1	 3D Printing in Complex Liver Tumors
		15.2.2	 3D Printing in Liver Transplantation
		15.2.3	 3D Printing Cutting Guides for Resected Specimens
		15.2.4	 Hepatic Bioprinting
	15.3	 3D Printing in Pancreatic Diseases
		15.3.1	 Pancreatic Malignancies
		15.3.2	 3D Printed Biodegradable Drug Delivery
		15.3.3	 3D Printing in Laparoscopic Pancreatic Surgery
		15.3.4	 Endoscopic Retrograde Cholangiopancreatography (ERCP) Training Models
		15.3.5	 Bioprinting Applications
	15.4	 3D Printing in Gastrointestinal Diseases
		15.4.1	 Stomach
		15.4.2	 Bowel
	15.5	 3D Printing of the Abdominal Vasculature
		15.5.1	 Aorta and Aortic Aneurysm
		15.5.2	 Visceral Arteries
	15.6	 3D Printing in Genitourinary Diseases
		15.6.1	 Tissue Engineering
	15.7	 Summary
	References
16: 3D Printing in the Management of Breast Cancer
	16.1	 Introduction
	16.2	 Breast Cancer Localization and Breast Conservation Surgery
	16.3	 Breast Reconstruction Surgery
	16.4	 Communication Between Interdisciplinary Physician Providers and with Patients
	16.5	 Education and Simulation
	16.6	 Quality Control
	16.7	 Future Directions
		16.7.1	 Personalized Radiation Therapy
		16.7.2	 Bioprinting
	16.8	 Conclusion
	References
17: RSNA-ACR 3D Printing Registry
	17.1	 Introduction
	17.2	 Registry Design
		17.2.1	 Purpose and Scope
		17.2.2	 Privacy
	17.3	 Data Dictionary
		17.3.1	 Data Dictionary Format
		17.3.2	 Section Overview
	17.4	 Example Cases
		17.4.1	 Spine
		17.4.2	 Mitral Valve Prolapse
		17.4.3	 Pelvic Tumor
		17.4.4	 Mandibular Reconstruction
	17.5	 Conclusions
	References
18: Establishing a Medical 3D Printing Lab and Considerations for Ensuring Quality of the 3D Printed Medical Parts
	18.1	 Introduction
	18.2	 3D Printing at an Academic Healthcare Facility (HCF)
		18.2.1	 Electronic Medical Record (EMR) 3D Printing Order
		18.2.2	 Requisition and Consultation: Defining Anatomic Model Requirements
		18.2.3	 Imaging (and Reimaging) for 3D Printing
		18.2.4	 Segmentation
		18.2.5	 Computer-Aided Design (CAD)
		18.2.6	 Radiologist Review
		18.2.7	 Referring Provider Review
		18.2.8	 3D Printing
		18.2.9	 Post-Processing
		18.2.10 Engineer Review
		18.2.11 Data Capture
		18.2.12 Model Handoff
		18.2.13 Miscellaneous: Standard Operating Procedures (SOPs)
		18.2.14 Miscellaneous: Digital Surgical Plan (DSP) Templates
		18.2.15 Summary of Potential Errors and Other Tips
	18.3	 Conclusions
	References
19: 3D Printing in Medical Education
	19.1	 Introduction
	19.2	 Medical Student Education
		19.2.1	 3D Printing in Medical Libraries
		19.2.2	 3D Printing in an Anatomy Lab
		19.2.3	 Problem-Based Learning Anatomic Models
		19.2.4	 3D Printed Anatomical Puzzles
		19.2.5	 Simulators for Medical Students
		19.2.6	 Assessment of Medical Trainees
	19.3	 Postgraduate (Resident and Fellow) Medical Education
		19.3.1	 Abdomen
		19.3.2	 Brain
		19.3.3	 Ophthalmology
		19.3.4	 Otorhinolaryngology
		19.3.5	 Cardiovascular
		19.3.6	 Obstetrics, Gynecology, and Fetal Medicine
		19.3.7	 Plastic Surgery
		19.3.8	 Orthopedic Procedures
		19.3.9	 Interventional Radiology
	19.4	 Dental Education
	References
20: Biofabricated Tissues and Organs
	20.1	 Introduction to 3D Printing for Fabricating Biomaterial Structures
		20.1.1	 Extrusion-Based Scaffold Fabrication Techniques
		20.1.2	 Extrusion-Based Bioprinting
		20.1.3	 Physical Fusion Techniques
		20.1.4	 Photocuring Techniques
	20.2	 3D Printing-Enabled Design Freedom for Tissue Engineering
		20.2.1	 Porosity for Biological Tuneability: Cell Alignment and Directionality
		20.2.2	 Porosity for Mechanical Tuneability
		20.2.3	 Personalization
		20.2.4	 Vascularization
		20.2.5	 Drug Loading and Controlled Release
	20.3	 Research and Translation Pathways for Biofabricated Tissues and Organs
		20.3.1	 Current State-of-the-Art and Research Pathways
			20.3.1.1 Musculoskeletal Tissues: Bone and Spinal Fusion, Cartilage, Muscle, Ligament/Tendon
			20.3.1.2 Cardiovascular Tissues: Cardiac Muscle, Heart Valves, Vascular Grafts
			20.3.1.3 Skin
			20.3.1.4 Renal Tissues: Kidney Tissues and Tubules
			20.3.1.5 Urological Tissues: Pelvic Floor, Hernia
			20.3.1.6 Nerve Guides, Spinal Regeneration
		20.3.2	 Regulation of Scaffold-Only Products
		20.3.3	 Combination Products
	20.4	 Conclusions and Future Directions
	References
21: FDA Regulatory Pathways and Technical Considerations for the 3D Printing of Medical Models and Devices
	21.1	 Introduction
	21.2	 The FDA’s Role
	21.3	 Brief Overview of FDA Regulatory Pathways for Medical Devices
		21.3.1	 Resources
		21.3.2	 Classification
			21.3.2.1	 Class I
			21.3.2.2	 Class II: Premarket Notification [510(k)]
			21.3.2.3	 Class III: Premarket Approval (PMA)
		21.3.3	 Clinical Studies
		21.3.4	 Pre-submission Meetings
		21.3.5	 Other Regulatory Pathways
			21.3.5.1	 Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)
			21.3.5.2	 De Novo
			21.3.5.3	 Combination Products
	21.4	 Regulatory Landscape for 3D-Printed Medical Devices
		21.4.1	 Medical Implants and Accessories
		21.4.2	 Surgical Visualization Models
		21.4.3	 Prosthetics and Quality of Life Accessories
	21.5	 Printing Materials
		21.5.1	 Characterization
		21.5.2	 Biological Suitability
	21.6	 The Design Process
		21.6.1	 Engineering Tools
			21.6.1.1	 Failure Mode Effects Analysis (FMEA)
			21.6.1.2	 User-Centric and  Patient-Centric Design
		21.6.2	 Patient-Matching Workflow
	21.7	 The Manufacturing Process
		21.7.1	 Software/Hardware Interactions
		21.7.2	 Building a Part
			21.7.2.1	 Part Orientation and Location in the Build Volume
			21.7.2.2	 Support Materials
			21.7.2.3	 Machine Parameters
			21.7.2.4	 Post-processing
	21.8	 Verification and Process Validation
		21.8.1	 Quality Systems
		21.8.2	 Monitoring
		21.8.3	 Test Coupons
	21.9	 Conclusions
	References
22: Augmented and Virtual Reality in Medicine
	22.1	 Introduction
	22.2	 Technology Overview
		22.2.1	 Distinguishing AR and VR Technologies
		22.2.2	 Form Factors: A Trend Toward Mobile HMDs
		22.2.3	 Logistics of Implementation
	22.3	 Applications in Medicine
	22.4	 VR, AR, and 3D Printing
		22.4.1	 Unique Advantages of VR/AR
	22.5	 Creating and Using Content for VR/AR
		22.5.1	 Content Formats
		22.5.2	 Segmented Models
		22.5.3	 Direct Image Data
		22.5.4	 Mixed Reality as a Medium for Content Generation
		22.5.5	 Controller and Hand-Based Input
		22.5.6	 Haptics and Physical-Based Interactions
	22.6	 Summary
	References
Afterword
In Memory of Our Angel Son Chinmay: Safe in Loving Arms Forever (06/12/2015–02/23/2023)