4th Edition

Biological Performance of Materials Fundamentals of Biocompatibility, Fourth Edition

By Jonathan Black, Jonathan Black Copyright 2006
    518 Pages 75 B/W Illustrations
    by CRC Press

    Bioengineers need a thorough grounding in biocompatibility - the biological performance of materials. Until now, there were no publications suitable for a neophyte in the field; prior publications were either not comprehensive or focused on rather narrow interests. Drawing on the author's 35 years of experience as a teacher, researcher, and consultant in biomaterials science and engineering (BSE), Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition focuses primarily on principles of biological performance at a relatively fundamental level, analyzing interactions between living organisms and nonliving materials used in medical devices - the subject that sets BSE apart as a distinct field of investigation.

    Following an introductory section, the book is divided into three sections: the material response to biological systems, host response to biomaterials, and test methods for determining biological response in vitro as well as in animal models and clinical settings.

    Supplemental "Interparts" summarize the physical properties of commonly used metallic, polymeric, and ceramic biomaterials. They also provide a guide to understanding the clinical performance of implanted biomaterials.

    GENERAL CONSIDERATIONS

    Biocompatibility: Definitions and Issues
    Introduction
    Biological Performance
    Consensus Definitions
    Discussion
    The Discipline of Biomaterials
    Afterword: Paradigmatic Shift

    Introduction to the Biological Environment
    General Considerations
    Comparison of External and Internal Conditions
    Problems in Definition of the Biological Environment
    Elements of the Biological Environment
    Implant Life History
    Preimplantation Handling Effects

    MATERIAL RESPONSE: FUNCTION AND
    DEGRADATION OF MATERIALS
    IN VIVO

    Swelling and Leaching
    Introduction
    Fick's Laws of Diffusion
    Absorption
    Examples of Undesirable Absorption
    Osmotic Equilibrium
    Leaching
    Example of Planned Leaching: Drug Release
    Effects of Swelling and Leaching

    Corrosion and Dissolution
    Chemistry of Corrosion
    Classification of Reactions
    The Pourbaix Diagram
    The Electrochemical Series
    Corrosion Rate
    Potential-Current Relationships in Corrosion
    Forms of Corrosion
    Corrosion in Implant Applications
    Engineering Variables Affecting Corrosion Rates
    Corrosion Factors Peculiar to Biological Environments
    Ceramic Dissolution
    Polymer Dissolution
    Final Remarks

    Reactions of Biological Molecules with
    Biomaterial Surfaces
    Introduction
    Denaturation
    Organometallic Compounds
    Mechanical Aspects of Interfaces
    Results of Interfacial Adhesion of Molecules
    Effects of Charged Interfaces and Ions
    Final Comments

    Mechanics of Materials: Deformation and Failure
    Introduction
    Mechanics of Materials
    Elastic Modulus
    Yield Strength
    Fracture Strength
    Final Comment

    Friction and Wear
    Introduction
    Friction
    Lubrication
    Wear
    Conclusions

    Interpart 1
    Implant Materials: Properties
    Introduction
    Metals
    Polymers
    Ceramics
    Composites

    HOST RESPONSE: BIOLOGICAL EFFECTS OF IMPLANTS

    The Inflammatory Process
    Introduction
    The Inflammatory Response
    Infection
    Effects of Implant Degradation Products
    A Final Comment

    Coagulation and Hemolysis
    Introduction
    The Coagulation Cascade
    Approaches to Thromboresistant Materials Development
    Hemolysis
    Final Comments

    Adaptation
    Introduction
    Tissue Growth Strategies
    Examples of Adaptation in Implant Applications
    A Final Comment on Adaptation

    In Vitro Tissue Growth and Replantation
    General Considerations
    What Is Tissue Engineering?
    The Cell-Receptor Paradigm
    Matrices and Cell Sources
    Thinking Twice about Tissue Engineering
    Some Final Comments

    Allergic Foreign Body Response
    Specific vs. Nonspecific Response
    Mechanisms of Immune Response
    Classes of Hypersensitivity Reactions
    Hypersensitivity Reactions Associated with Implants
    Final Comment

    Chemical and Foreign-Body Carcinogenesis
    Definitions
    Chemical Carcinogenesis
    Foreign Body Carcinogenesis
    Nonspecific Carcinogenesis
    Evidence for Implant Carcinogenesis in Humans

    Mineral Metabolism
    Introduction
    Iron Metabolism
    Chromium Metabolism
    Human Dietary Metal Intake

    Systemic Distribution and Excretion
    Introduction
    Movement of Solid Bodies
    Transport of Dissolved Species
    Distribution and Excretion of Dissolved Species
    Final Comment

    Effects of Degradation Products on Remote
    Organ Function
    Introduction
    Examples of Systemic Effects
    A Review of Systemic Aspects of Host Response
    A Final Comment

    Interpart 2
    Implant Materials: Clinical Performance
    Introduction
    An Example: Total Hip Replacement
    A Final Word

    METHODS OF TESTING FOR BIOLOGICAL PERFORMANCE

    In Vitro Test Methods
    Test Strategies
    In Vitro Test Types
    Tissue Culture Tests
    Blood Contact Tests
    Final Comments

    In Vivo Implant Models
    Introduction
    Test Types
    A Final Comment

    Clinical Testing of Implant Materials
    Goal of Clinical Trials
    Design of Clinical Trials
    Conclusions from Clinical Trials
    Aspects of the Decision for General Clinical Use
    Final Comments

    Standardization and Regulation of
    Implant Materials
    Historical Perspective
    Drug Standardization Activities
    Biomaterials Standardization Activities
    U.S. Federal Regulation of Medical Devices and Biomaterials
    Regulation of Materials for Implants
    The Biomaterials Supply "Crisis"

    Design and Selection of Implant Materials
    Introduction
    The Design Process
    The Value of Prospective Design

    Clinical Performance of Biomaterials
    Historical Aspects
    Procedures for Device Retrieval and Analysis
    Common Concerns about Device Retrieval and Analysis
    Proposed National Implant Data Retrieval and Analysis
    Program (NIDRA)
    Elements of a NIDRA System
    Autopsy Retrieval Studies
    Concluding Remarks

    Glossary
    Introduction
    Glossary
    Deprecated Terms

    Biography

    Jonathan Black, Jonathan Black