Part 1: Materials Science and Engineering
1.1 Overview of Biomaterials
1.1.1 Introduction to Biomaterials Science: An Evolving, Multidisciplinary Endeavor,
1.1.2 A History of Biomaterials
Section 1.2 Properties of Materials
1.2.1 Introduction: Properties of Materials—the Palette of the
1.2.2 The Nature of Matter and Materials
1.2.3 Bulk Properties of Materials
1.2.4 Surface Properties and Surface Characterization of Biomaterials
1.2.5 Role of Water in Biomaterials
Section 1.3 Classes of Materials Used in Medicine
1.3.1 The Materials Side of the Biomaterials Relationship
1.3.2 Polymers: Basic Principles
1.3.2A Polyurethanes
1.3.2B Silicones
1.3.2C Fluorinated Biomaterials
1.3.2D The Organic Matrix of Restorative Composites and Adhesives
1.3.2E Hydrogels
1.3.2F Degradable and Resorbable Polymers
1.3.2G Applications of “Smart Polymers¿ as Biomaterials
1.3.3 Metals: Basic Principles
1.3.3A Titanium Alloys, Including Nitinol
1.3.3B Stainless Steels
1.3.3C CoCr Alloys
1.3.3D Biodegradable Metals
1.3.4 Ceramics, Glasses, and Glass-Ceramics: Basic Principles
1.3.4A Natural and Synthetic Hydroxyapatites
1.3.4B Structural Ceramic Oxides
1.3.5 Carbon Biomaterials
1.3.6 Natural Materials
1.3.6A Processed Tissues
1.3.6B Use of Extracellular Matrix Proteins and Natural Materials in Bioengineering
1.3.7 Composites
1.3.8A Microparticles
1.3.8B Nanoparticles
Section 1.4: Materials Processing
1.4.1 Introduction to Materials Processing for Biomaterials
1.4.2 Physicochemical Surface Modification of Materials Used in Medicine
1.4.3A Nonfouling Surfaces
1.4.3B Nonthrombogenic Treatments and Strategies
1.4.4 Surface-Immobilized Biomolecules
1.4.5 Surface Patterning
1.4.6 Medical Fibers and Biotextiles
1.4.7 Textured and Porous Biomaterials
1.4.8 Biomedical Applications of Additive Manufacturing
Part 2: Biology and Medicine
Section 2.1 Some Background Concepts
2.1.1 Introduction to Biology and Medicine—Key Concepts in the Use of Biomaterials in Surgery and Medical Devices
2.1.2 Adsorbed Proteins on Biomaterials
2.1.3 Cells and Surfaces in Vitro
2.1.4 Functional Tissue Architecture, Homeostasis, and Responses to Injury
2.1.5 The Extracellular Matrix and Cell–Biomaterial Interactions
2.1.6 Effects of Mechanical Forces on Cells and Tissues
Section 2.2 Host Reaction to Biomaterials and Their Evaluation
2.2.1 Introduction to Biological Responses to Materials
2.2.2 Inflammation, Wound Healing, the Foreign-Body Response, and Alternative Tissue Responses
2.2.3 Innate and Adaptive Immunity: The Immune Response to Foreign Materials
2.2.4 The Complement System
2.2.5 Systemic and Immune Toxicity of Implanted Materials
2.2.6 Blood Coagulation and Blood–Material Interactions
2.2.7 Tumorigenesis and Biomaterials
2.2.8 Biofilms, Biomaterials, and Device-Related Infections
Section 2.3 Characterization of Biomaterials
2.3.1 How Well Will It Work? Introduction to Testing Biomaterials
2.3.2 The Concept and Assessment of Biocompatibility
2.3.3 In Vitro Assessment of Cell and Tissue Compatibility
2.3.4 In Vivo Assessment of Tissue Compatibility
2.3.5 Evaluation of Blood–Materials Interactions
2.3.6 Animal Surgery and Care of Animals
Section 2.4 Degradation of Materials in the Biological Environment
2.4.1 Introduction: The Body Fights Back–Degradation of Materials in the Biological Environment
2.4.2 Chemical and Biochemical Degradation of Polymers Intended to Be Biostable
2.4.3 Metallic Degradation and the Biological Environment
2.4.4 Degradative Effects of the Biological Environment on Ceramic Biomaterials
2.4.5 Pathological Calcification of Biomaterials
Section 2.5 Applications of Biomaterials
2.5.1 Introduction to Applications of Biomaterials
2.5.2A Cardiovascular Medical Devices: Heart Valves, Pacemakers and Defibrillators Mechanical Circulatory Support, and Other Intracardiac Devices
2.5.2B Cardiovascular Medical Devices: Stents, Grafts, Stent-Grafts and Other Endovascular Devices
2.5.3 Extracorporeal Artificial Organs and Therapeutic Devices
2.5.4 Orthopedic Applications
2.5.5 Dental Applications
2.5.6 Ophthalmologic Applications: Introduction
2.5.7 Bioelectronic Neural Implants
2.5.8 Burn Dressings and Skin Substitutes
2.5.9 Description and Definition of Adhesives, and Related Terminology
2.5.10 Biomaterials for Immunoengineering
2.5.11 Biomaterials-Based Model Systems to Study Tumor–Microenvironment Interactions
2.5.12 Drug Delivery Systems
2.5.13 Responsive Polymers in the Fabrication of Enzyme-Based Biosensors
Section 2.6 Applications of Biomaterials in Functional Tissue Engineering
2.6.1 Rebuilding Humans Using Biology and Biomaterials
2.6.2 Overview of Tissue Engineering Concepts and Applications
2.6.3 Tissue Engineering Scaffolds
2.6.4 Micromechanical Design Criteria for Tissue-Engineering Biomaterials
2.6.5 Tendon Tissue-Engineering Scaffolds
2.6.6 Bone Tissue Engineering
2.6.7 Biomaterials for Cardiovascular Tissue Engineering
2.6.8 Soft Tissue Engineering
Part 3: The Medical Product Life Cycle
3.1.1 Introduction: Biomaterials in Medical Devices
3.1.2 Total Product Lifecycle for Biomaterial-Based Medical Devices
3.1.3 Safety and Risk Considerations in Medical Device Development
3.1.4 Sterilization and Disinfection of Biomaterials for Medical Devices
3.1.5 Verification and Validation: From Bench to Human Studies
3.1.6 Commercial Considerations in Medical Device Development
3.1.7 Regulatory Constraints for Medical Products Using Biomaterials
3.1.8 Role of Standards for Testing and Performance Requirements of Biomaterials
3.1.9 Medical Device Failure—Implant Retrieval, Evaluation, and Failure Analysis
3.1.10 Legal Concepts for Biomaterials Engineers
3.1.11 Moral and Ethical Issues in the Development of Biomaterials and Medical Products
Appendix A: Properties of Biological Fluids
Appendix B: Properties of Soft Materials
Appendix C: Chemical Composition of Metals and Ceramics Used for Implants
Appendix D: The Biomaterials Literature
Appendix E: Assessment of Cell and Matrix Components in Tissues (Online only)