Biological Performance of Materials Fundamentals of Biocompatibility, Fourth Edition

Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition focuses on principles of biological performance at a fundamental level, analyzing interactions between organisms and nonliving materials used in medical devices. 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. Subsections summarize the physical properties of commonly used metallic, polymeric, and ceramic biomaterials and provide a guide to understanding the clinical performance of implanted biomaterials.

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 CONSIDERATIONSBiocompatibility: 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 ConditionsProblems in Definition of the Biological EnvironmentElements of the Biological Environment Implant Life History Preimplantation Handling Effects MATERIAL RESPONSE: FUNCTION ANDDEGRADATION OF MATERIALSIN VIVOSwelling and Leaching Introduction Fick's Laws of DiffusionAbsorption Examples of Undesirable Absorption Osmotic EquilibriumLeaching Example of Planned Leaching: Drug ReleaseEffects of Swelling and LeachingCorrosion and Dissolution Chemistry of Corrosion Classification of ReactionsThe Pourbaix DiagramThe Electrochemical SeriesCorrosion RatePotential-Current Relationships in Corrosion Forms of Corrosion Corrosion in Implant ApplicationsEngineering Variables Affecting Corrosion Rates Corrosion Factors Peculiar to Biological Environments Ceramic DissolutionPolymer DissolutionFinal RemarksReactions of Biological Molecules withBiomaterial SurfacesIntroduction DenaturationOrganometallic CompoundsMechanical Aspects of Interfaces Results of Interfacial Adhesion of Molecules Effects of Charged Interfaces and Ions Final CommentsMechanics of Materials: Deformation and Failure Introduction Mechanics of Materials Elastic Modulus Yield StrengthFracture Strength Final CommentFriction and Wear Introduction FrictionLubricationWear ConclusionsInterpart 1Implant Materials: Properties Introduction MetalsPolymersCeramicsComposites HOST RESPONSE: BIOLOGICAL EFFECTS OF IMPLANTSThe Inflammatory Process Introduction The Inflammatory ResponseInfectionEffects of Implant Degradation Products A Final Comment Coagulation and Hemolysis Introduction The Coagulation CascadeApproaches to Thromboresistant Materials DevelopmentHemolysis Final CommentsAdaptationIntroduction Tissue Growth StrategiesExamples 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 CommentsAllergic Foreign Body Response Specific vs. Nonspecific Response Mechanisms of Immune Response Classes of Hypersensitivity Reactions Hypersensitivity Reactions Associated with ImplantsFinal CommentChemical and Foreign-Body Carcinogenesis DefinitionsChemical CarcinogenesisForeign Body Carcinogenesis Nonspecific Carcinogenesis Evidence for Implant Carcinogenesis in Humans Mineral MetabolismIntroduction Iron MetabolismChromium MetabolismHuman Dietary Metal Intake Systemic Distribution and Excretion Introduction Movement of Solid Bodies Transport of Dissolved Species Distribution and Excretion of Dissolved Species Final CommentEffects of Degradation Products on RemoteOrgan Function Introduction Examples of Systemic Effects A Review of Systemic Aspects of Host ResponseA Final Comment Interpart 2Implant Materials: Clinical Performance Introduction An Example: Total Hip ReplacementA Final Word METHODS OF TESTING FOR BIOLOGICAL PERFORMANCEIn Vitro Test Methods Test Strategies In Vitro Test Types Tissue Culture TestsBlood Contact Tests Final CommentsIn Vivo Implant ModelsIntroduction Test TypesA 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 CommentsStandardization and Regulation ofImplant Materials Historical Perspective Drug Standardization ActivitiesBiomaterials Standardization ActivitiesU.S. Federal Regulation of Medical Devices and Biomaterials Regulation of Materials for Implants The Biomaterials Supply "Crisis"Design and Selection of Implant MaterialsIntroduction The Design ProcessThe Value of Prospective Design Clinical Performance of BiomaterialsHistorical Aspects Procedures for Device Retrieval and Analysis Common Concerns about Device Retrieval and Analysis Proposed National Implant Data Retrieval and AnalysisProgram (NIDRA) Elements of a NIDRA System Autopsy Retrieval StudiesConcluding RemarksGlossary Introduction GlossaryDeprecated Terms