Biomaterials Science by Ratner, Buddy D. -- Read -- Imperial Library of Trantor

Index

Cover image Title page Table of Contents Copyright Contributors Preface How to Use this Book Introduction: Biomaterials Science: An Evolving, Multidisciplinary Endeavor

Biomaterials and Biomaterials Science Key Definitions The Evolution of the Biomaterials Field Examples of Today’s Biomaterials Applications Characteristics of Biomaterials Science Subjects Integral to Biomaterials Science Biomaterials Literature Biomaterials Societies Summary

A History of Biomaterials

Biomaterials before World War II World War II to the Modern Era: The Surgeon/Physician Hero Designed Biomaterials The Contemporary Era (Modern Biology and Modern Materials) Conclusions

Part 1: Materials Science and Engineering

Section I.1: Properties of Materials

Chapter I.1.1. Introduction: Properties of Materials: The Palette of the Biomaterials Engineer Chapter I.1.2. The Nature of Matter and Materials

Introduction Atoms and Molecules Molecular Assemblies Surfaces Conclusion Bibliography

Chapter I.1.3. Bulk Properties of Materials

Introduction Load, Nominal Stress, Extension, and Nominal Strain True Stress and True Strain Shear Stress and Shear Strain Bulk Mechanical Properties Determined from Stress–Strain Plots Other Bulk Properties Worked Example bibliography

Chapter I.1.4. Finite Element Analysis in Biomechanics

Introduction Overview of the Finite Element Method Conclusion Bibliography

Chapter I.1.5. Surface Properties and Surface Characterization of Biomaterials

Introduction Surface Analysis Techniques: Principles and Methods Studies with Surface Methods Conclusions Acknowledgment Bibliography

Chapter I.1.6. Role of Water in Biomaterials

Water: The Special Molecule Water: Structure Water: Significance for Biomaterials Bibliography

Section I.2: Classes of Materials Used in Medicine

Chapter I.2.1. Introduction: The Diversity and Versatility of Biomaterials Chapter I.2.2. Polymers: Basic Principles

Introduction The Polymer Molecule Molecular Weight Connecting Physical Behavior with Chemical Characteristics Polymer Synthesis Case Studies The Present and The Future Bibliography

A. Polyurethanes

Introduction Anatomy of a Polyurethane Molecule The Physical Properties of Polyurethanes Polyurethane Synthesis Concluding Remarks Bibliography

B. Silicones

Chemical Structure and Nomenclature Conclusion Acknowledgments Bibliography

C. Fluorinated Biomaterials

Introduction Interesting Fluoropolymer Chemical and Physical Properties Derived from their Polymer Chemistry, Molecular Structure, and Bonding Distinguishing the Different Fluoropolymers Biomedical Applications Summary Glossary Bibliography

D. Acrylics

Introduction Mono- and Multi-Methacrylate Monomers Summary Acknowledgments Bibliography

Chapter i.2.3. Metals: Basic Principles

Introduction Steps in the Fabrication of Metallic Biomaterials Microstructures and Properties of Implant Metals Concluding Remarks Bibliography

A. Titanium and Nitinol (NiTi)

Fabrication Corrosion Resistance Biocompatibility and Surface Modification Mechanical Properties NiTi Alloy Surface Modifications of NiTi Applications Bibliography

B. Stainless Steels

Introduction Metallurgical and Chemical Considerations Mechanical Properties Corrosion Behavior Summary Bibliography

Chapter I.2.4. Ceramics, Glasses, and Glass-Ceramics: Basic Principles

Types of Bioceramics: Tissue Attachment Characteristics and Processing of Bioceramics Nearly Inert Crystalline Ceramics Porous Ceramics Bioactive Glasses and Glass-Ceramics Bioactivity Reaction Stages Calcium Phosphate Ceramics Calcium Phosphate Coatings Calcium Phosphate Implants: Mechanical Properties and Porosity Resorbable Calcium Phosphates Calcium Phosphate Bone Cements Clinical Applications of HA References

A. Natural and Synthetic Hydroxyapatites

Introduction Applications of Hap Ceramics Synthesis of Hap Ceramics Structure Characterization of Hap Ceramics Stability, Biocompatibility, and Osteointegration of Hap Ceramics References

B. Alumina

Introduction Production of Alumina Structure of Alumina Properties of Alumina Alumina as a Biomaterial Alumina in Joint Replacements Alumina in Bone Spacers Alumina in Dental Applications Other Applications of Alumina Alumina Matrix Composites Conclusion Bibliography

Chapter I.2.5. Hydrogels

Introduction Classification and Basic Structures Of Hydrogels Synthesis of Hydrogels Swelling Behavior of Hydrogels Determination of Structural Characteristics Biomedical Hydrogels “Smart” or “Intelligent,” Stimuli-Responsive Hydrogels and Their Applications Biomedical Applications of Hydrogels Bibliography

Chapter I.2.6. Degradable and Resorbable Biomaterials

Introduction Definitions Relating to the Processes of Degradation Versus Biodegradation, and Erosion Versus Bioerosion Overview of Currently Available Degradable Polymers Applications of Synthetic, Degradable Polymers as Biomaterials Bibliography

Chapter I.2.7. Engineered Natural Materials

Introduction to Commonly Used Natural Materials HA in Medicine: The Old and the New Recreating the Extracellular Matrix Meeting the Translational Challenge Glossary of Acronyms Disclosure Statement bibliography

Chapter I.2.8. Pyrolytic Carbon for Long-Term Medical Implants

Introduction Elemental Carbon Pyrolytic Carbon (PyC) Steps in the Fabrication of Pyrolytic Carbon Components Biocompatibility of Pyrolytic Carbon Clinical Applications Conclusion Bibliography

Chapter I.2.9. Composites

Introduction Reinforcing Systems Matrix Systems Fabrication of Composites Absorbable Matrix Composites Non-Absorbable Matrix Composites Summary Appendix 1: Mechanical and Physical Properties of Composites Short-Fiber Composites Particulate Composites Glossary of Terms Bibliography

Chapter I.2.10. Non-Fouling Surfaces

Introduction Background Conclusions and Perspectives Bibliography

Chapter I.2.11. Applications of “Smart Polymers” as Biomaterials

Introduction Smart Polymers in Solution Smart Polymer–Protein Bioconjugates in Solution Smart Polymers and their Biomolecule Conjugates on Surfaces Site-Specific Smart Polymer Bioconjugates Smart Polymer Hydrogels Conclusions Bibliography

Chapter I.2.12. Physicochemical Surface Modification of Materials Used in Medicine

Introduction General Principles Methods for Modifying the Surfaces of Materials Layer-By-Layer Deposition and Multilayer Polyelectrolyte Deposition Conclusions bibliography

Chapter I.2.13. Surface Patterning

Introduction Common Concerns in Biomolecular Surface Patterning Patterning Techniques Conclusions Bibliography

Chapter I.2.14. Medical Fibers and Biotextiles

Fiber Forming Polymers Medical Fibers Textile Structures Finishing Biotextile Products Future Directions Acknowledgments References

Chapter I.2.15. Textured and Porous Materials

Introduction Stimulating Tissue Ingrowth Disrupting Fibrosis Promoting Angiogenesis Conclusion Bibliography

Chapter I.2.16. Electrospinning Fundamentals and Applications

Motivation For Using Electrospun Membranes Historical Perspective Characterization Methods Biomedical Applications for Electrospun Materials Summary Bibliography

Chapter I.2.17. Surface-Immobilized Biomolecules

Introduction Patterned Surface Compositions Immobilized Biomolecules and their Uses Immobilized Cell Ligands and Cells Immobilization Methods Conclusions Bibliography

Chapter I.2.18. Biomimetic Materials

Introduction: what are biomimetic materials? A Classification of Biomimetic Materials The Origins of Biomimicry Some Attractions of Biomimicry Limitations of Biomimicry The Future of Biomimicry in Biomaterials Science Acknowledgment Worked Example BIBLIOGRAPHY

Chapter I.2.19. Microparticles and Nanoparticles

Introduction Microparticles Microparticle Preparation Submicron-Sized Particles Nanoparticles Materials used for Nanoparticle Synthesis Nanoparticle Preparation Surface Modification of Micro/Nanoparticles Characterization of Micro/Nanoparticles Applications of Micro/Nanoparticles Challenges Facing Nanoparticles Concluding Remarks Bibliography

Part 2: Biology and Medicine

Section II.1: Some Background Concepts

Chapter II.1.1. Introduction: Biology and Medicine – Key Concepts in the Use of Biomaterials in Surgery and Medical Devices Chapter II.1.2. Adsorbed Proteins on Biomaterials

Introduction Examples of the Effects of Adhesion Proteins on Cellular Interactions with Materials The Adsorption Behavior of Proteins at Solid–Liquid Interfaces Molecular Spreading Events: Conformational and Biological Changes in Adsorbed Proteins The Importance of Adsorbed Proteins in Biomaterials Bibliography

Chapter II.1.3. Cells and Surfaces in vitro

Introduction A Basic Overview of Cell Culture Understanding Cell–Substrate Interactions Cell Response to Substrate Chemistry Cell Response to Substrate Topography Cell Response to Substrate Elasticity Cell Response to Mechanical Deformation (Strain) Comparison and Evaluation of Substrate Cues Summary GLOSSARY OF TERMS Bibliography

Chapter II.1.4. Cell Function and Response to Injury

Cells: Function and Response to Injury Tissues and the Extracellular Matrix Normal Cell Housekeeping The Plasma Membrane: Protection, Nutrient Acquisition, and Communication The Cytoskeleton: Cellular Integrity and Movement The Nucleus: Central Control Rough and Smooth Endoplasmic Reticulum, and Golgi Apparatus: Biosynthetic Machinery Lysosomes, Proteasomes and Peroxisomes: Waste Disposal Mitochondria: Energy Generation Cell Specialization and Differentiation Cell Regeneration and Proliferation Cell Injury and Regeneration Causes of Cell Injury Pathogenesis of Cell Injury Responses to Cell Injury Reversible Versus Irreversible Injury Necrosis Apoptosis Bibliography

Chapter II.1.5. Tissues, the Extracellular Matrix, and Cell–Biomaterial Interactions

Structure and Function of Normal Tissues Basic Tissues Tissue Response to Injury: Inflammation, Repair, and Regeneration Techniques for Analysis of Cells and Tissues Regenerative Capacity of Cells and Tissues Cell/Tissue–Biomaterials Interactions Bibliography

Chapter II.1.6. Effects of Mechanical Forces on Cells and Tissues (The Liquid–Cell Interface)

Cellular Detection of Mechanical Forces Blood Vessels Interstitial Fluid Bone and Cartilage Summary Bibliography

Chapter II.1.7. Stem Cells: Key Concepts

Introduction Stem Cell Potency Stem Cell Niches Conclusions Bibliography

Section II.2: Host Reaction to Biomaterials and Their Evaluation

Chapter II.2.1. Introduction: “Biological Responses to Biomaterials”

The Inflammatory Reaction to Biomaterials Systemic and Remote Effects Thromboembolic Complications Tumorigenesis Infection Bibliography

Chapter II.2.2. Inflammation, Wound Healing, and the Foreign-Body Response

Overview Acute Inflammation Chronic Inflammation Granulation Tissue Foreign-Body Reaction Fibrosis/Fibrous Encapsulation Bibliography

Chapter II.2.3. Innate and Adaptive Immunity: The Immune Response to Foreign Materials

Overview Innate and Adaptive Immunity Components of Innate Immunity Recognition in Innate Immunity Effector Mechanisms of Innate Immunity Complement Neutrophils and Macrophages: Cells of Innate Immunity Adaptive Immunity Components of Adaptive Immunity Antibodies T Lymphocytes Th Cells Tc Cells Recognition in Adaptive Immunity B Cell and Antibody Recognition T Cell Recognition Effector Pathways in Adaptive Immunity Overview: Immunity to Pathogens Pathology Associated with Immune Responses Pathogenesis of Antibody-Mediated Disease Pathogenesis of T Cell-Mediated Disease Immune Responses to Transplanted Tissues, Biomaterials, and Synthetic Substances Bibliography

Chapter II.2.4. The Complement System

Introduction Classical Pathway Lectin Pathway Alternative Pathway Membrane Attack Complex Control Mechanisms Complement Receptors Clinical Correlates Summary and Future Directions Bibliography

Chapter II.2.5. Systemic Toxicity and Hypersensitivity

Kinetics and the Nature of Biomaterials Components Toxico-Dynamic Considerations Metallic Materials Non-Metallic Biomaterials Adverse Effects of Defense Mechanisms Hypersensitivity and Immunotoxicity Allergy and Biomaterials Types of Allergies Type I Hypersensitivity Type IV Hypersensitivity Atopy Immunologic Toxicity of Biomaterials Implant Allergy Other Interactions Concluding Remarks Bibliography

Chapter II.2.6. Blood Coagulation and Blood–Materials Interactions

Platelets Coagulation Mechanisms of Coagulation Control Mechanisms Conclusions Acknowledgment Bibliography

Chapter II.2.7. Tumors Associated with Biomaterials and Implants

General Concepts Association of Implants with Human and Animal Tumors Pathobiology of Foreign-Body Tumorigenesis Conclusions Bibliography

Chapter II.2.8. Biofilms, Biomaterials, and Device-Related Infections

Introduction Bacterial Biofilms Biofilm Microbiology and Infectious Disease Device-Related Infection Clinical Examples of Biofilm Infections Prevention and Treatment Conclusions bibliography

Section II.3: Biological Testing of Biomaterials

Chapter II.3.1 How Well Will It Work? Introduction to Testing Biomaterials Chapter II.3.2. The Concept and Assessment of Biocompatibility

Biocompatibility Today Toxicology The Products of Extrinsic Organisms Colonizing the Biomaterial Mechanical Effects Cell–Biomaterials Interactions Summary of Ideas to this Point New Developments are Changing the Paradigm of Biocompatibility Conclusions Bibliography

Chapter II.3.3. In Vitro Assessment of Cell and Tissue Compatibility

Introduction Background Concepts In Vitro Assays to Assess Cell and Tissue Compatibility in Biomaterial/Medical Device Evaluation for Regulatory Purposes Application-Specific in Vitro Assays Considered in Proof-of-Concept Testing Future Challenges in in Vitro Assessment of Cell and Tissue Compatibility Summary Remarks Bibliography

Chapter II.3.4. In Vivo Assessment of Tissue Compatibility

Introduction Selection of in Vivo Tests According to Intended Use Biomaterial and Device Perspectives in IN Vivo Testing Specific Biological Properties Assessed by In Vivo Tests Selection of Animal Models for In Vivo Tests Future Perspectives on In Vivo Medical Device Testing Bibliography

Chapter II.3.5. Evaluation of Blood–Materials Interactions

Introduction Background and Principles of Blood–Materials Interactions Assessment Evaluation of BMI Conclusions Bibliography

Chapter II.3.6. Animal Surgery and Care of Animals

Introduction Ethical And Regulatory Overview Information Resources Surgical Facility Design Preoperative Preparation and Monitoring Anesthesia Analgesia Species-Specific Recommendations Summary bibliography

Chapter II.3.7. Large Animal Models in Cardiac and Vascular Biomaterials Research and Assessment

Introduction Recommendations for Preclinical Assessment Current Recommendations Responsible Use of Animals Animal Models and Species Consideration Existing Models Existing Models Existing Models Testing Hierarchies Current Recommendations and Future Directions Acknowledgments Bibliography

Chapter II.3.8. Microscopy for Biomaterials Science

Magnification, Resolution, and Contrast Configurations Light Microscopy Fluorescence Microscopy Digital Imaging Electron Microscopy The Revolution in Optical Microscopy Conclusions Bibliography

Section II.4: Degradation of Materials in the Biological Environment

Chapter II.4.1. Introduction: The Body Fights Back – Degradation of Materials in the Biological Environment Chapter II.4.2. Chemical and Biochemical Degradation of Polymers Intended to be Biostable

Polymer Degradation Processes Hydrolytic Biodegradation Oxidative Biodegradation Conclusion Acknowledgments Bibliography

Chapter II.4.3. The Biodegradation of Biodegradable Polymeric Biomaterials

Introduction Characteristics of Biodegradable Polymers Kinetics of Biodegradation Influence of Biodegradation on Properties of Biodegradable Polymers and their Application Summary Bibliography

Chapter II.4.4. Degradative Effects of the Biological Environment on Metals and Ceramics

Metallic Corrosion Influence of the Biological Environment Corrosion and Corrosion Control in the Biological Environment Ceramic Degradation Summary Bibliography

Chapter II.4.5. Pathological Calcification of Biomaterials

Introduction The Spectrum of Pathologic Biomaterials and Medical Device Calcification Assessment of Biomaterials Calcification Mechanisms of Biomaterials Calcification Prevention of Calcification Conclusions Bibliography

Section II.5: Applications of Biomaterials

Chapter II.5.1. Introduction: Applications of Biomaterials

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Chapter II.5.2. Nonthrombogenic Materials and Strategies: Case Study

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Chapter II.5.3. Introduction to Cardiovascular Medical Devices

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A. Substitute Heart Valves

Introduction Heart Valve Function and Dysfunction Heart Valve Replacement and Repair Mechanical and Tissue Valve Replacement Devices: Types and Complications Transcatheter Valve Replacement Engineered Heart Valves Bibliography

B. Endovascular Stents, Vascular Grafts, and Stent Grafts

Introduction Angioplasty and Stents Vascular Grafts Stent Grafts Engineered Vascular Grafts References

C. Other Cardiovascular Devices

Introduction Pacemakers and Icds (For Cardiac Arrhythmias) Cardiac Assist and Replacement Devices (For Heart Failure) Miscellaneous Cardiovascular Devices Conclusion References

D. Implantable Cardiac Assist Devices and IABPs

Clinical Need and Applications Ventricular Assist Device Design and Blood-Contacting Materials Conclusions Acknowledgments Bibliography

Chapter II.5.4. Artificial Cells

Basic Features of Artificial Cells Research into the Applications of Artificial Cells Artificial Cells in Hemoperfusion Nanobiotechnology for Partial Artificial Red Blood Cells Nanobiotechnology for Complete Artificial Red Blood Cells Cells, Islets, Stem Cells, Genetically Engineered Cells, and Microorganisms Artificial Cells Containing Stem Cells in Regenerative Medicine Gene and Enzyme Therapy Drug Delivery Other Areas of Artificial Cells The Future of Artificial Cells Acknowledgments BIBLIOGRAPHY

Chapter II.5.5. Extracorporeal Artificial Organs

Introduction Bibliography

Chapter II.5.6. Orthopedic Applications

Introduction Orthopedic Biomaterials Market Orthopedic Biomaterials Orthopedic Biomaterials Design Structure and Properties of Calcified Tissues Biomaterials Development: A History of Total Hip Arthroplasty New Developments: Total Disc Arthroplasty Current Biomaterials in Total Arthroplasty New Alloys and Surface Coatings Orthopedic Biomaterials: Clinical Concerns Bibliography

Chapter II.5.7. Dental Implantation

Patient Profiles, Dental Needs, and Surgical Implants: 1950s–2010s Anatomical and Imaging Considerations Biomaterials Tissue Integration: Biomaterial and Biomechanical Aspects Bibliography

Chapter II.5.8. Adhesives and Sealants

Introduction The Logic of Adhesion Procedures Adherend Surface Pretreatments to Enhance Bond Strength and Durability Hard Tissue Adhesives: Bone and Tooth Cements GLOSSARY OF TERMS Bibliography

Chapter II.5.9. Ophthalmologic Applications: Introduction

Overview of Eye Anatomy Eye-Related Conditions and Statistics Bibliography

A. Biomaterials: Contact Lenses

Introduction General Properties and Corneal Requirements Contact Lens Materials Surface Modifications Specialty Lenses Contact Lens Solutions Bibliography

B. Intraocular Lens Implants: A Scientific Perspective

Introduction to Intraocular Lens Implants, The Optics of the Eye and Cataracts Why are IOLS Successful? Emerging Functional Variations of IOLS Biomaterials for IOLS IOLS with Variations of Optical Function Overall Summary and Future of IOLS Bibliography

C. Corneal Inlays and Onlays

History of Corneal Inlays and Onlays Synthetic Biomaterials in the Cornea Optical Requirements Biological Requirements Commercial Attempts at Synthetic Corneal Inlays and Onlays Permeable Intracorneal Lenses Impermeable Intracorneal Lenses Synthetic Materials for Corneal Onlays Corneal Inlays and Onlays Today The Future of Corneal Inlays and Onlays Bibliography

D. Ophthalmologic Applications: Glaucoma Drains and Implants

Historical Perspective on the Treatment of Glaucoma New Drainage Devices and Materials Under Development Summary References

E. The Development of a Retinal Prosthesis: A Significant Biomaterials Challenge

Introduction Overview of the Visual System Retinal Prostheses Other Materials Concerns Directions for the Future Summary Acknowledgments Bibliography

Chapter II.5.10. Bioelectrodes

Introduction Electrode–Electrolyte Interface Equivalent Circuit Models Factors Influencing Material Selection Electrode Materials Applications Summary Bibliography

Chapter II.5.11. Cochlear Prostheses

Introduction Overview of the Auditory System Cochlear Prostheses Materials and Electrode Arrays Future Directions Summary Acknowledgments Glossary of Terms Bibliography

Chapter II.5.12. The Role of Biomaterials in Stimulating Bioelectrodes

Introduction Neurostimulation Fundamental Requirements of a Bioelectrode Principles of Charge Injection Active Chemical Processes and Electrochemical Reversal Passive Chemical Processes and Mechanical Interaction of Electrode and Tissue Neurostimulation Applications Future Directions Bibliography

Chapter II.5.13. Medical Biosensors

Introduction Basics of Biosensing Challenges in Biosensing Biofouling Prevention Methods Effects of Biofouling on Sample Removal Systems Point-of-Care Measurements Enabling Distributed Diagnosis and Home Healthcare Summary Acknowledgments Bibliography

Chapter II.5.14. Burn Dressings and Skin Substitutes

Skin: The Largest Organ Skin Substitutes Composite Autologous Tissue and Skin Transfer Combined Therapy with Vacuum Assisted Closure (VAC) The Marketplace for Burn Dressings and Skin Substitutes Bibliography

Chapter II.5.15. Sutures

Genesis and Common Uses Description of Surgical Suture Manufacturing Process and Intended Use Performance Evaluation Regulatory Considerations Newer Trends and Future Development Alternatives to Suture Bibliography

Chapter II.5.16. Drug Delivery Systems

A Introduction Introduction: Principles, Origins, and Evolution of Controlled Drug Delivery Systems (CDDS) Bibliography

B. Injected Nanocarriers

B.1 Introduction Bibliography

B.2. Pegylation of Drugs and Nanocarriers

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B.3. Targeting

Introduction Immunotargeting Carbohydrates Nutrient-Based Targeting Peptide-Based Targeting Summary Bibliography

B.4. Polymer–Drug Conjugates

Introduction Poly(HPMA) as a Drug Carrier Poly(glutamic acid) (PG) as a Drug Carrier Cyclodextrin Polymers as Drug Carriers Polyacetals as Drug Carriers Bibliography

B.5. Liposomes

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B.6. Polymeric Micelles

Introduction Bibliography

B.7. Dendrimers

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B.8. Nucleic Acid Delivery

Introduction Gene Expression Gene Knockdown Ligand Binding Biomaterials and Nucleic Acid Delivery Viral Delivery Non-Viral Delivery: Introduction Local Gene Delivery Extracellular Requirements for Efficient Nucleic Acid Delivery Intracellular Requirements for Efficient Nucleic Acid Delivery Escaping from the Endosome Nuclear Entry and Delivery Bibliography

B.9. Polymeric and Albuminated Drug Nanoparticles

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C. Injected Depot DDS

Injected Depot Systems Bibliography

D. Implants and Inserts

Introduction Implants Pump-Based DDS Infusion Pumps Inserts The Future Bibliography

E. Smart DDS

Environmentally-Responsive Systems References

F. Transdermal DDS

Introduction Passive Transdermal Delivery Systems (passive tdds) Active Transdermal Delivery Systems (Active TDDS) Glossary Bibliography

G. Oral Drug Delivery

Features of the Gastrointestinal Tract Controlled Release in the GI Tract Bibliography

Chapter II.5.17. Diagnostic Applications of Biomaterials

Overview of Diagnostics The Pre-Analytical Phase The Analytical Phase Interpretation Summary Acknowledgments Bibliography

Chapter II.5.18. Medical Applications of Silicones

Medical Applications Biocompatibility Biodurability Conclusion Acknowledgments Bibliography

Section II.6: Applications of Biomaterials in Functional Tissue Engineering

Chapter II.6.1 Introduction: Rebuilding Humans Using Biology and Biomaterials

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Chapter II.6.2. Overview of Tissue Engineering Concepts and Applications

General Introduction Goals of Tissue Engineering and Classification Components of Tissue Engineering Materials Scaffold Design Development of Tissue Engineering Constructs Models for Tissue Engineering Applications of Tissue Engineering Current Challenges and Future Directions Future Perspectives Bibliography

Chapter II.6.3. Tissue Engineering Scaffolds

Scaffold Design Scaffold Materials Applications of Scaffolds Scaffold Processing Techniques Characterization of Processed Scaffolds Cell Seeding and Culture in Three-Dimensional Scaffolds Conclusions Bibliography

Chapter II.6.4. Cell Sources for Tissue Engineering: Mesenchymal Stem Cells

Introduction Mesenchymal Stem Cells MSC-NICHE Other Sources of MSCs A New Era of MSC-Based Therapies Long-Term Goals Synopsis Acknowledgments Bibliography

Chapter II.6.5. Micromechanical Design Criteria for Tissue Engineering Biomaterials

Introduction Micromechanical Control of Tissue Form and Function Microscale Design of Biomimetic Scaffolds for Tissue Reconstruction Cell and ECM Mechanics as Key Regulators of Tissue Development Biomaterials for Stem Cell Development and Tissue Regeneration Molecular Mechanisms of Cellular Mechanotransduction Implications for Future Materials Design for In Situ Tissue Engineering Conclusion Acknowledgements Bibliography

Chapter II.6.6. Bioreactors for Tissue Engineering

Introduction Bioreactor Design Considerations Cartilage Tissue Engineering with Mechanical Loading Tissue Engineering of Anatomically-Shaped Human Bone Cardiac Tissue Engineering with Mechanical Stretch Cardiac Tissue Engineering with Electrical Stimulation and Medium Perfusion Tissue Engineering of Heart Valves with Mechanical Stimulation and Perfusion Tissue Engineering of Blood Vessels with Pulsatile Medium Flow Challenges in Bioreactor Design Worked Examples Acknowledgment Bibliography

Chapter II.6.7. Bone Tissue Engineering

Introduction Bone Biology Cells Involved Bone Tissue Development Bone Grafts Bone Graft Substitutes Porosity in Bone Graft Substitutes Dimension in Bone Graft Substitutes In Vitro Culture Techniques for Bone Graft Substitutes Conclusion Bibliography

Chapter II.6.8. Cartilage and Ligament Tissue Engineering: Biomaterials, Cellular Interactions, and Regenerative Strategies

Introduction to Cartilage and Ligament Tissue Engineering Cartilage Tissue Engineering Ligament Tissue Engineering Acknowledgment Bibliography

Chapter II.6.9. Blood Vessel Tissue Engineering

Introduction Enabling Technologies Tissue Engineering Approaches Concluding Discussion Bibliography

Chapter II.6.10. Heart Valve Tissue Engineering

Design Criteria and Challenges in Tissue-Engineered Heart Valve (Tehv) Tissue Engineering Approaches to Heart Valves Challenges for Future Translation of Engineered Tissue Valves to the Clinic Conclusions Bibliography

Chapter II.6.11. Cardiac Muscle Tissue Engineering

Introduction Cardiovascular Disease and the Need for Engineered Myocardium Considerations for Engineering Cardiac Muscle Some Representative Studies in Cardiac Tissue Engineering Challenges and Future Applications Worked Example Solution Acknowledgment Bibliography

Chapter II.6.12. Tissue-Engineered Skin Substitutes

Introduction Types of Skin Substitutes Commercial Production of Skin Substitutes The Transcyte® System Conclusion bibliography

Chapter II.6.13. Esophageal and Gastrointestinal Tissue Engineering

Introduction Anatomy and Structure Tissue Engineering of GI Tissues Bibliography

Chapter II.6.14. Neuronal Tissue Engineering

Challenges to Neural Tissue Healing and the Enabling Therapeutic Role of Biomaterials Biomaterials-Based Cues for the Treatment of Neural Injury/Disease Conclusions Bibliography

Chapter II.6.15. Immunoisolation

Introduction Principles of Immunoisolation Devices for Immunoisolation Encapsulated Cell Therapy Applications Concluding Perspectives Bibliography

Chapter II.6.16. Tissue Engineering with Decellularized Tissues

Introduction Rationale for the Decellularization of Tissues and Organs and the Use of Decellularized Tissues as Scaffolds in Tissue Engineering and Regenerative Medicine Methods of Decellularization ECM Configuration Composition of Extracellular Matrix Mechanisms by Which ECM Scaffolds Function as Inductive Templates for Tissue Reconstruction Host Cell and Immune Responses to Implanted ECM Scaffolds Potential Immune Activating Molecules within ECM Scaffolds Innate Immune Response to ECM Scaffolds T-Cell-Mediated Immune Response to ECM Scaffolds Angiogenesis and New ECM Deposition Response to Mechanical Stimuli Conclusion Bibliography

Part 3: Practical Aspects of Biomaterials

Section III.1: Implants, Devices, and Biomaterials: Special Considerations

Chapter III.1.1 Introduction: Implants, Devices, and Biomaterials: Special Considerations

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Chapter III.1.2. Sterilization of Implants and Devices

Introduction Sterilization Technologies Material Compatibility Optimizing Chances for Finding Material Compatibility Solutions Sterility and Patient Safety Product and Patient Safety Issues Terminal Sterilization Validation Principles Summary and Future Challenges Bibliography

Chapter III.1.3. Correlation, Materials Properties, Statistics and Biomaterials Science

Introduction Biocompatibility and Medical Device Performance Data, Information, and Statistics Correlation Aspects of the Bioreaction to Biomaterials The Case for Correlation: A Brief Review of the Literature Issues Complicating Simple Correlation Multivariate Correlation Conclusions Bibliography

Chapter III.1.4. Device Failure Mode Analysis

Role of Biomaterials–Tissue Interactions: Effect of Materials on the Patient and the Effect of the Patient on the Materials Testing of Biomaterials–Design Configurations Biological Testing of Implants Raw Materials, Fabrication, and Sterilization Packaging, Shipping, and Storage Clinical Handling and Surgical Procedure The Recipient Conclusions Bibliography

Chapter III.1.5. Implant Retrieval and Evaluation

Introduction Goals Components of Implant Retrieval and Evaluation Approach to Assessment of Host and Implant Responses The Role of Implant Retrieval in Device Development What Clinically Useful Information has been Learned from Implant Retrieval and Analysis? Conclusions Bibliography General References

Section III.2: Voluntary Standards, Regulatory Compliance, and Non-Technical Issues

Chapter III.2.1 Introduction: Voluntary Standards, Regulatory Compliance, and Other Non-Technical Issues

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Chapter III.2.2. Commercialization: What it Takes to get a Product to Market

Introduction The Need You Propose to Solve Market Size and Growth Effect on Various Constituencies Clinical Trials Business and Commercialization Issues The Stages of Life Science: From Concept to Adoption Bibliography

Chapter III.2.3. Voluntary Consensus Standards

What are Standards? Who uses Standards? Who writes Standards? Biocompatibility Standards Tissue-Engineered Medical Products Nanotechnology Workshop and Symposia Internationalization of Standards

Chapter III.2.4. Regulatory Overview for Medical Products Using Biomaterials

Introduction Global Regulatory Strategy According to Intended Use Design Control and Risk Analysis Biocompatibility Assessment for Biomaterials in Medical Devices Manufacturing Controls and Post-Market Oversight Premarket Clearance (510(k)), Premarket Approval (PMA) Or “CE MARK” Clinical and Animal Trials of Unapproved Devices Sterilization, Shelf-Life, and Aging Innovative Technologies Require Special Considerations Summary bibliography

Chapter III.2.5. Principles of Reimbursement for Medical Devices

Significance of Reimbursement Background Points of Service The “Hospital Bill” and the “Claim” Claims Processing Payment Coverage Claims Databases

Chapter III.2.6. Corporate Considerations on Biomaterials and Medical Devices: Case Studies in Regulation and Reimbursement

Regulatory Strategy Medicare Reimbursement Design Controls Manufacturing Controls Registration, Listing, and Inspection Intellectual Property Further Reading Bibliography

Chapter III.2.7. Ethical Issues in Biomaterials and Medical Devices

Introduction Protection of Patients Good Laboratory Practice Good Manufacturing Practice Good Clinical Practice Protection of Research Subjects Conflicts of Interest Conclusion A Practical Example: The Design of a Novel Heart Valve Bibliography

Chapter III.2.8. Legal Aspects of Biomaterials

Introduction Intrauterine Devices Pedicle Screws Silicone Breast Implants Implantable Cardiac Defibrillators Artificial Heart Valves Hip/Knee Prosthesis Implants Preemption Science in the Courtroom Biomaterials Access Insurance Act Liability of the Design Engineer Device Marketing and Promotion Defensive Manufacturing and Marketing Conclusion Bibliography

Chapter III.2.9. Clinical Trials for Medical Devices

Introduction Critique of Medical Device RCTs Medical Device Regulatory Trials Improving Observational Studies Adaptive and Bayesian Trials Clinical Trials for Transcatheter Valves Summary Bibliography

Chapter III.2.10. Entrepreneurship in Biomaterials

Introduction The Entrepreneurial Ecosystem and the Start-Up Process Building a Successful Start-Up Conclusions Bibliography

Chapter III.2.11. Postmarket Considerations in Biomaterials and Medical Devices

The FDA’s Postmarketing Programs Passive Event Surveillance: Spontaneous Reports Biomaterials and Medwatch Active Event Surveillance FDA Tracking AND Clinical Trial Requirements New FDA Device Safety Initiatives Summary: What does Postmarketing Surveillance Teach Us? Bibliography

Appendix A: Properties of Biological Fluids Appendix B: Properties of Soft Materials

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Appendix C Appendix D: The Biomaterials Literature

Biomaterials Journals (or Journals with Significant Biomaterials Content) Biomaterials Books

Index

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