Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition
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Summary
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.
Table of Contents
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
