Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition

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Edition: 4th
Format: Hardcover
Pub. Date: 2005-12-20
Publisher(s): CRC Press
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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

Part I General Considerations
Biocompatibility: Definitions and Issues
3(14)
Introduction
3(2)
Biological Performance
5(1)
Consensus Definitions
6(1)
Discussion
7(3)
The Discipline of Biomaterials
10(2)
Afterword: Paradigmatic Shift
12(5)
References
14(1)
Bibliography
15(2)
Introduction to the Biological Environment
17(18)
General Considerations
17(1)
Comparison of External and Internal Conditions
17(1)
Problems in Definition of the Biological Environment
18(2)
Elements of the Biological Environment
20(2)
Implant Life History
22(6)
Preimplantation Handling Effects
28(7)
References
29(1)
Bibliography
30(5)
Part II Material Response: Function and Degradation of Materials In Vivo
Swelling and Leaching
35(14)
Introduction
35(1)
Fick's Laws of Diffusion
35(1)
Absorption
36(2)
Examples of Undesirable Absorption
38(4)
Osmotic Equilibrium
42(1)
Leaching
43(1)
Example of Planned Leaching: Drug Release
44(2)
Effects of Swelling and Leaching
46(3)
References
46(1)
Bibliography
47(2)
Corrosion and Dissolution
49(24)
Chemistry of Corrosion
49(1)
Classification of Reactions
50(1)
The Pourbaix Diagram
51(3)
The Electrochemical Series
54(2)
Corrosion Rate
56(1)
Potential-Current Relationships in Corrosion
57(1)
Forms of Corrosion
58(6)
Corrosion in Implant Applications
64(2)
Engineering Variables Affecting Corrosion Rates
66(1)
Corrosion Factors Peculiar to Biological Environments
67(1)
Ceramic Dissolution
68(1)
Polymer Dissolution
69(1)
Final Remarks
70(3)
References
70(1)
Bibliography
71(2)
Reactions of Biological Molecules with Biomaterial Surfaces
73(14)
Introduction
73(1)
Denaturation
74(1)
Organometallic Compounds
74(3)
Mechanical Aspects of Interfaces
77(3)
Results of Interfacial Adhesion of Molecules
80(2)
Effects of Charged Interfaces and Ions
82(1)
Final Comments
83(4)
References
84(1)
Bibliography
84(3)
Mechanics of Materials: Deformation and Failure
87(20)
Introduction
87(1)
Mechanics of Materials
87(3)
Elastic Modulus
90(6)
Yield Strength
96(1)
Fracture Strength
97(7)
Final Comment
104(3)
References
104(1)
Bibliography
105(2)
Friction and Wear
107(18)
Introduction
107(1)
Friction
107(2)
Lubrication
109(5)
Wear
114(8)
Conclusions
122(3)
References
122(1)
Bibliography
123(2)
Interpart 1 Implant Materials: Properties
125(202)
Introduction
125(1)
Metals
126(3)
Polymers
129(2)
Ceramics
131(1)
Composites
132(7)
References
134(1)
Bibliography
135(4)
Part III Host Response: Biological Effects of Implants
The Inflammatory Process
139(26)
Introduction
139(1)
The Inflammatory Response
139(11)
Infection
150(5)
Effects of Implant Degradation Products
155(5)
A Final Comment
160(5)
References
160(2)
Bibliography
162(3)
Coagulation and Hemolysis
165(18)
Introduction
165(1)
The Coagulation Cascade
165(5)
Approaches to Thromboresistant Materials Development
170(6)
Hemolysis
176(3)
Final Comments
179(4)
References
180(1)
Bibliography
181(2)
Adaptation
183(20)
Introduction
183(1)
Tissue Growth Strategies
183(3)
Examples of Adaptation in Implant Applications
186(11)
A Final Comment on Adaptation
197(6)
References
199(2)
Bibliography
201(2)
In Vitro Tissue Growth and Replantation
203(22)
General Considerations
203(1)
What Is Tissue Engineering?
204(2)
The Cell-Receptor Paradigm
206(4)
Matrices and Cell Sources
210(4)
Thinking Twice about Tissue Engineering
214(6)
Some Final Comments
220(5)
References
222(1)
Bibliography
223(2)
Allergic Foreign Body Response
225(20)
Specific vs. Nonspecific Response
225(1)
Mechanisms of Immune Response
226(4)
Classes of Hypersensitivity Reactions
230(1)
Hypersensitivity Reactions Associated with Implants
230(10)
Final Comment
240(5)
References
241(2)
Bibliography
243(2)
Chemical and Foreign-Body Carcinogenesis
245(28)
Definitions
245(1)
Chemical Carcinogenesis
246(11)
Foreign Body Carcinogenesis
257(5)
Nonspecific Carcinogenesis
262(1)
Evidence for Implant Carcinogenesis in Humans
263(10)
References
268(2)
Bibliography
270(3)
Mineral Metabolism
273(18)
Introduction
273(1)
Iron Metabolism
274(9)
Chromium Metabolism
283(2)
Human Dietary Metal Intake
285(6)
References
288(1)
Bibliography
289(2)
Systemic Distribution and Excretion
291(26)
Introduction
291(1)
Movement of Solid Bodies
291(5)
Transport of Dissolved Species
296(5)
Distribution and Excretion of Dissolved Species
301(10)
Final Comment
311(6)
References
312(3)
Bibliography
315(2)
Effects of Degradation Products on Remote Organ Function
317(10)
Introduction
317(1)
Examples of Systemic Effects
318(3)
A Review of Systemic Aspects of Host Response
321(2)
A Final Comment
323(4)
References
325(1)
Bibliography
326(1)
Interpart 2 Implant Materials: Clinical Performance
327(132)
Introduction
327(3)
An Example: Total Hip Replacement
330(2)
A Final Word
332(5)
References
332(1)
Bibliography
333(4)
Part IV Methods of Testing for Biological Performance
In Vitro Test Methods
337(18)
Test Strategies
337(1)
In Vitro Test Types
338(1)
Tissue Culture Tests
338(9)
Blood Contact Tests
347(3)
Final Comments
350(5)
References
351(2)
Bibliography
353(2)
In Vivo Implant Models
355(28)
Introduction
355(3)
Test Types
358(12)
A Final Comment
370(13)
References
370(3)
Bibliography
373(1)
Appendices
374(9)
Clinical Testing of Implant Materials
383(20)
Goal of Clinical Trials
383(1)
Design of Clinical Trials
384(8)
Conclusions from Clinical Trials
392(2)
Aspects of the Decision for General Clinical Use
394(4)
Final Comments
398(5)
References
400(1)
Bibliography
401(2)
Standardization and Regulation of Implant Materials
403(24)
Historical Perspective
403(1)
Drug Standardization Activities
404(2)
Biomaterials Standardization Activities
406(9)
U.S. Federal Regulation of Medical Devices and Biomaterials
415(4)
Regulation of Materials for Implants
419(3)
The Biomaterials Supply ``Crisis''
422(5)
References
423(1)
Bibliography
424(3)
Design and Selection of Implant Materials
427(14)
Introduction
427(2)
The Design Process
429(9)
The Value of Prospective Design
438(3)
References
439(1)
Bibliography
440(1)
Clinical Performance of Biomaterials
441(18)
Historical Aspects
441(2)
Procedures for Device Retrieval and Analysis
443(4)
Common Concerns about Device Retrieval and Analysis
447(3)
Proposed National Implant Data Retrieval and Analysis Program (NIDRA)
450(1)
Elements of a NIDRA System
451(4)
Autopsy Retrieval Studies
455(1)
Concluding Remarks
456(3)
References
457(1)
Bibliography
457(2)
Glossary
459(12)
Introduction
459(1)
Glossary
460(9)
Deprecated Terms
469(2)
References
470(1)
Index 471

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