Biomaterials Science
An Introduction to Materials in Medicine
- 3rd Edition - October 25, 2012
- Imprint: Academic Press
- Editors: Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 3 7 4 6 2 6 - 9
- eBook ISBN:9 7 8 - 0 - 0 8 - 0 8 7 7 8 0 - 8
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 ap… Read more
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Request a sales quoteThe 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.
- 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
Undergraduate and graduate students and practitioners in biomedical engineering, life and biological sciences, materials, mechanical and engineering sciences, and medicine.
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
- Edition: 3
- Published: October 25, 2012
- Imprint: Academic Press
- Language: English
- Hardback ISBN: 9780123746269
- eBook ISBN: 9780080877808
BR
Buddy D. 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, USAAH
Allan S. 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, USAFS
Frederick J. 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, USAJL
Jack E. Lemons
Affiliations and expertise
Professor and Director of Biomaterials Laboratory Surgical Research, University of Alabama, USARead Biomaterials Science on ScienceDirect