Biomaterials Science

Biomaterials Science

An Introduction to Materials in Medicine

3rd Edition - October 25, 2012
There is a Newer Edition Available
  • Editors: Buddy Ratner, Allan Hoffman, Frederick Schoen, Jack Lemons
  • eBook ISBN: 9780080877808

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Description

The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine.

Key Features

  • Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently covers this area comprehensively" - Materials Today
  • Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials
  • Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank

Readership

Undergraduate and graduate students and practitioners in biomedical engineering, life and biological sciences, materials, mechanical and engineering sciences, and medicine.

Table of Contents

  • 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

    Bibliography

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

    Bibliography

    Chapter II.5.3. Introduction to Cardiovascular Medical Devices

    Bibliography

    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

    Bibliography

    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

    Bibliography

    B.6. Polymeric Micelles

    Introduction

    Bibliography

    B.7. Dendrimers

    Bibliography

    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

    Bibliography

    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

    Bibliography

    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

    Bibliography

    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

    Bibliography

    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

    Bibliography

    Appendix C

    Appendix D: The Biomaterials Literature

    Biomaterials Journals (or Journals with Significant Biomaterials Content)

    Biomaterials Books

    Index

Product details

  • No. of pages: 1573
  • Language: English
  • Copyright: © Academic Press 2012
  • Published: October 25, 2012
  • Imprint: Academic Press
  • eBook ISBN: 9780080877808
  • About the Editors

    Buddy Ratner

    Buddy D. Ratner, Michael L. and Myrna Darland Endowed Chair in Bioengineering and Professor of Chemical Engineering at the University of Washington, received his Ph.D. (1972) in polymer chemistry from the Polytechnic Institute of Brooklyn. From 1985-1996 he directed the NIH-funded National ESCA and Surface Analysis Center for Biomedical Problems (NESAC/BIO), and in 1996 he assumed the directorship of University of Washington Engineered Biomaterials (UWEB), an NSF Engineering Research Center. He is the editor of the Journal of Undergraduate Research in Bioengineering, a past president of the Society for Biomaterials and author of 400 scholarly works. Ratner is a fellow of the American Institute of Medical and Biological Engineering (AIMBE), the American Vacuum Society and a Fellow, Biomaterials Science and Engineering (FBSE). He served as president of AIMBE, 2002-2003. He is vice president of the Tissue Engineering Society International (TESI) 2003-2005. In 2002 Ratner was elected a member of the National Academy of Engineering, USA, and in 2004 he won the Founder’s Award for the Society For Biomaterials. His research interests include biomaterials, tissue engineering, polymers, biocompatibility, surface analysis of organic materials, self-assembly, nanobiotechnology and RF-plasma thin film deposition. Summary of Buddy Ratner’s awards and honors: 1989 Clemson Award for Contributions to the Biomaterials Literature 1990 Burlington Resources Foundation Faculty Achievement Award for Outstanding Research 1991 Perkin-Elmer Physical Electronics Award for Excellence in Surface Science 1991–1992 President, Society For Biomaterials 1993 Founding Fellow, American Institute of Medical and Biological Engineering (AIMBE) 1993 Fellow, American Vacuum Society; Vice President, AIMBE 1993 Fellow, Society For Biomaterials; Van Ness Lecturer, Rensselaer Polytechnic Institute 1998 C.M.A. Stine Award in Materials Science (AIChE); American Vacuu

    Affiliations and Expertise

    Professor of Chemical Engineering and Bioengineering, University of Washington, USA

    Allan Hoffman

    Allan Hoffman
    Professor Hoffman studied at M.I.T., where he received B.S., M.S., and Sc.D. degrees in Chemical Engineering between 1953 and 1957. He taught on the faculty of M.I.T. Chemical Engineering Department for a total of ten years. He also spent four years in industry. Since 1970 he has been Professor of Bioengineering at the University of Washington in Seattle, Washington. Professor Hoffman has over 330 publications, several books and chapters, 21 patents and several other patents pending. He is on the Editorial Boards of seven scientific journals. Summary of professional activities and awards include: •President, Society for Biomaterials, 1983-1984 •Clemson Award in Biomaterials, 1984 •Board of Governors, Controlled Release Society, 1991-1994 •Biomaterials Science Prize, Japanese Biomaterials Society, 1990 •Founders’ Award of the Society for Biomaterials, 2000 •Election to the National Academy of Engineering, 2005 In December, 1992, Hoffman's colleagues organized a symposium in Maui, Hawaii in honor of his 60th birthday. In December, 2002 his 70th birthday was celebrated at another special symposium, once again in Maui, Hawaii. Papers from the first symposium were published in the Journal of Biomaterials Science (Polymer Edition), along with a Festschrift book, and similar publications are in press at this time from the second symposium.

    Affiliations and Expertise

    Professor of Bioengineering, University of Washington, USA

    Frederick Schoen

    Frederick J. Schoen is Professor of Pathology and Health Sciences and Technology, Harvard Medical School; Director of Cardiac Pathology and Executive Vice-Chairman in the Department of Pathology at the Brigham and Women's Hospital (BWH) in Boston. Schoen received a B.S.E. (Materials and Metallurgical Engineering) from the University of Michigan (1966), a Ph.D. in Materials Science from Cornell University (1970) and an M.D. from the University of Miami School of Medicine (1974). Following a Surgery internship followed by residency in Anatomic Pathology and fellowship in Thoracic and Cardiovascular Pathology at the University of Florida, he joined BWH in 1980. Schoen has focused his research career on tissue-biomaterial interactions, structure-function-pathology correlations in the native heart valves, heart valve substitutes and other cardiovascular prostheses, calcification of bioprosthetic tissues, heart transplantation, and cardiovascular applications of tissue engineering. Schoen has leadership responsibilities in academic programs in the Department of Pathology, Harvard Medical School and the Harvard-MIT Division of Health Sciences and Technology (HST); he currently chairs the HST Faculty Appointments Committee and the Graduate (Curriculum) Committee, and is an active teacher of courses in pathology, cardiovascular pathology, and biomaterials and tissue engineering. He chairs the BWH Education Committee. Schoen is author or co-author of approximately 375 manuscripts in journals and books. He authored Interventional and Surgical Cardiovascular Pathology: Clinical Correlations and Basic Principles (1989); and was Co-Editor of Biomaterials Science: An Introduction to Materials in Medicine (1st Edition 1996, 2nd Edition 2004), and Silver’s Cardiovascular Pathology, 3rd Edition (2001). He is Past-President of the Society For Biomaterials (SFB) and the Society for Cardiovascular Pathology, and was Founding Fellow of the American In

    Affiliations and Expertise

    Professor of Pathology and Health Sciences and Technology, Harvard Medical School, USA

    Jack Lemons

    Affiliations and Expertise

    Professor and Director of Biomaterials Laboratory Surgical Research, University of Alabama, USA

    Latest reviews

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    • ELVAN Y. Mon Oct 25 2021

      Biomaterials Science

      This is an indispensable reference book in the biomaterials area.