BIOMATERIALS An Introduction SECOND EDITION BIOMATERIALS An Introduction SECOND EDITION Joon B. Park and Roderic S. Lakes The University of Iowa Iowa City, Iowa SPRINGER SCIENCE+BUSINESS MEDIA, LLC Library of Congress Cataloging-in-Publication Data Pack, Joon 8u. B10materlals all Introduct1on I Joan B. Park and Rnderle S. Lakes. -- 2nd ed. p. em. Includes bibllograohlcal references and Index. ISBN 978-1-4757-2158-4 ISBN 978-1-4757-2156-0 (eBook) DOI 10.1007/978-1-4757-2156-0 1. Biomedlcal materials. I. Lakes, Roderlc S. II. Tltle. R857.M3P37 1992 610' .28--dc20 92-23214 CIP 10 9 8 7 6 5 4 3 2 © 1992, 1979 Springer Science+Business Media New Yark Originally published by Plenum Press, New York in 1992 Sof'tcover reprint of the hardcover 2nd edition 1992 All rights reserved No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise, without written permission from the Publisher PREFACE This book is intended as a general introduction to the uses of artificial materials in the human body for the purposes of aiding healing, correcting deformities, and restoring lost function. It is an outgrowth of an undergraduate course for senior students in biomedical engineering, and it is offered as a text to be used in such courses. Topics include biocompatibility, techniques to minimize cor rosion or other degradation of implant materials, principles of materials science as it relates to the use of materials in the body, and specific uses of materials in various tissues and organs. It is expected that the student will have successively completed elementary courses in the mechanics of deformable bodies and in anatomy and physiology, and preferably also an introductory course in materials science prior to undertaking a course in biomaterials. Many quantitative examples are included as exercises for the engineering student. We recognize that many of these involve unrealistic simplifications and are limited to simple mechanical or chemical aspects of the implant problem. We offer as an apology the fact that biomaterials engineering is still to a great extent an empirical discipline that is complicated by many unknowns associated with the human body. In recognition of that fact, we have endeavored to describe both the successes and the failures in the use of materials in the human body. Also included are many photographs and illustrations of implants and devices as an aid to visualization. Any errors of commission or omission that have remained in spite of our efforts at correction are our responsibility alone. We thank Bea Park and Diana Lakes for their patience and support during a lengthy undertaking. Joon B. Park Roderic S. Lakes Iowa City, Iowa v CONTENTS Chapter 1 • INTRODUCTION TO BIOMATERIALS................ 1 1.1. Historical Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.2. Performance of Biomaterials .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Problems .............................. " . . .. . . . . . .. . . . . . . . . . . .. . 5 Symbols/ Definitions .............................................. 6 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Chapter 2 • THE STRUCTURE OF SOLIDS...................... 7 2.1. Atomic Bonding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2. Crystal Structure ............................................. 9 2.2.1. Atoms of the Same Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.2.2. Atoms of Different Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2.3. Imperfections in Crystalline Structures .......................... 13 2.4. Long-Chain Molecular Compounds (Polymers) . . . . . . . . . . . . . . . . . . . 15 2.5. Supercooled and Network Solids ............................... 19 2.6. Composite Material Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Problems ........................................................ 26 Symbols/ Definitions .............................................. 26 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Chapter 3 • CHARACTERIZATION OF MATERIALS I............. 29 3.1. Mechanical Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3.1.1. Stress-Strain Behavior. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3.1.2. Mechanical Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 3.1.3. Viscoelasticity.......................................... 39 3.2. Thermal Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 3.3. Phase Diagrams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 vii viii CONTENTS 3.4. Strengthening by Heat Treatments .............................. 55 3.4.1. Metals................................................. 55 3.4.2. Ceramics and Glasses ................................... 56 3.4.3. Polymers and Elastomers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 3.5. Surface Properties and Adhesion ............................... 56 Problems ........................................................ 59 Symbols/Definitions .............................................. 60 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Chapter 4 • CHARACTERIZATION OF MATERIALS II ............ 63 4.1. Electrical Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4.2. Optical Properties ............................................ 67 4.3. X-Ray Absorption ............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 4.4. Density and Porosity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 4.5. Acoustic and Ultrasonic Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 4.6. Diffusion Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Symbols/Definitions .............................................. 76 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Chapter 5 • METALLIC IMPLANT MATERIALS................... 79 5.1. Stainless Steels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 5.1.1. Types and Compositions of Stainless Steels. . . . . . . . . . . . . . . . . 80 5.1.2. Properties of Stainless Steel .............................. 80 5.1.3. Manufacturing of Implants Using Stainless Steel. . . . . . . . . . . . 81 5.2. Co-Based Alloys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 5.2.1. Types and Compositions of Co-Based Alloys. . . . . . . . . . . . . . . 83 5.2.2. Properties of Co-Based Alloys. . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 5.2.3. Manufacturing of Implants Using Co-Based Alloys. . . . . . . . . . 86 5.3. Ti and Ti-Based Alloys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 5.3.1. Compositions of Ti and Ti-Based Alloys. . . . . . . . . . . . . . . . . . . 89 5.3.2. Structure and Properties of Ti and Ti Alloys. . . . . . . . . . . . . . . . 89 5.3.3. Manufacturing of Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 5.4. Dental Metals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 5.4.1. Dental Amalgam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 5.4.2. Gold .................................................. 94 5.4.3. Nickel-Titanium Alloys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 5.5. Other Metals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 5.6. Corrosion of Metallic Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 5.6.1. Electrochemical Aspects ................................. 100 5.6.2. Pourbaix Diagrams in Corrosion . . . . . . . . . . . . . . . . . . . . . . . . .. 102 5.6.3. Rates of Corrosion and Polarization Curves. . . . . . . . . . . . . . .. 105 CONTENTS ix 5.6.4. Corrosion of Available Metals ........................... , 106 5.6.5. Minimization of Corrosion: Case Studies. . . . . . . . . . . . . . . . . .. 107 Problems ........................................................ 111 Symbols/Definitions .............................................. 113 Bibliography .................................................... , 114 Chapter 6 • CERAMIC IMPLANT MATERIALS................... 117 6.1. Structure-Property Relationship of Ceramics..................... 117 6.1.1. Atomic Bonding and Arrangement ........................ 117 6.1.2. Physical Properties ..................................... , 118 6.2. Aluminum Oxides ............................................ 121 6.3. Calcium Phosphate ........................................... 122 6.3.1. Structure of Calcium Phosphate. . . . . . . . . . . . . . . . . . . . . . . . . .. 122 6.3.2. Properties of Hydroxyapatite. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 123 6.3.3. Manufacturing of Hydroxyapatite. . . . . . . . . . . . . . . . . . . . . . . .. 123 6.4. Glass-Ceramics........... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 126 6.4.1. Formation of Glass-Ceramics. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 126 6.4.2. Properties of Glass-Ceramics ............. . . . . . . . . . . . . . . .. 129 6.5. Other Ceramics .............................................. , 130 6.6. Carbons..................................................... 131 6.6.1. Structure of Carbons .................................... 131 6.6.2. Properties of Caroon .................................... 132 6.6.3. Manufacturing of Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 134 6.7. Deterioration of Ceramics ..................................... 135 Problems ............................................ . . . . . . . . . . .. 139 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 140 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 140 Chapter 7 • POLYMERIC IMPLANT MATERIALS................. 141 7.1. Polymerization............................................... 141 7.1.1. Condensation or Step Reaction Polymerization ............. 141 7.1.2. Addition or Free Radical Polymerization. . . . . . . . . . . . . . . . . .. 142 7.2. Effect of Structural Modification and Temperature on Properties ... 144 7.2.1. Effect of Molecular Weight and Composition. . . . . . . . . . . . . .. 145 7.2.2. Effect of the Side-Chain Substitution, Cross-Linking, and Branching .......................................... 146 7.2.3. Effect of Temperature on Properties. . . . . . . . . . . . . . . . . . . . . .. 146 7.3. Polymeric Implant Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 147 7.3.1. Polyamides (Nylons) .................................... 148 7.3.2. Polyethylene............................................ 150 7.3.3. Polypropylene.......................................... 151 7.3.4. Polyacrylates ........................................... 152 x CONTENTS 7.3.5. Fluorocarbon Polymers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 157 7.3.6. Rubbers ............................................... 157 7.4. High-Strength Thermoplastics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 159 7.5. Deterioration of Polymers ..................................... 161 7.5.1. Chemical Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 161 7.5.2. Sterilization Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 162 7.5.3. Mechanochemical Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 162 7.5.4. In Vivo Environmental Effects. . . . . . . . . . . . . . . . . . . . . . . . . . .. 163 Problems ........................................................ 165 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 167 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 167 Chapter 8 • COMPOSITES AS BIOMATERIALS.................. 169 8.1. Structure .................................................... 169 8.2. Mechanics of Composites. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 170 8.3. Applications of Composite Biomaterials . . . . . . . . . . . . . . . . . . . . . . . .. 174 8.3.1. Dental Filling Composites. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 175 8.3.2. Porous Implants ........................................ 177 8.3.3. Fibrous and Particulate Composites in Orthopedic Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 180 Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 182 Symbols/Definitions .............................................. 182 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 183 Chapter 9 • STRUCTURE-PROPERTY RELATIONSHIPS OF BIOLOGICAL MATERIALS...................... 185 9.1. Proteins ..................................................... 186 9.1.1. Collagen............................................... 186 9.1.2. Elastin................................................. 187 9.2. Polysaccharides .............................................. 190 9.2.1. Hyaluronic Acid and Chondroitin. . . . . . . . . . . . . . . . . . . . . . . .. 191 9.2.2. Chondroitin Sulfate ..................................... 191 9.3. Structure-Property Relationship of Tissues. . . . . . . . . . . . . . . . . . . . . .. 192 9.3.1. Mineralized Tissue (Bone and Teeth) . . . . . . . . . . . . . . . . . . . . .. 193 9.3.2. Bone Remodeling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 204 9.3.3. Collagen-Rich Tissues ................................... 207 9.3.4. Elastic Tissues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 212 Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 219 Symbols/Definitions .............................................. 220 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 222 CONTENTS xi Chapter 10 • TISSUE RESPONSE TO IMPLANTS................ 223 10.1. Normal Wound Healing Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 223 10.1.1. Inflammation......................................... 223 10.1.2. Cellular Response to Repair. . . . . . . . . . . . . . . . . . . . . . . . . . .. 225 10.2. Body Response to Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 230 10.2.1. Cellular Response to Implants. . . . . . . . . . . . . . . . . . . . . . . . .. 231 10.2.2. Systemic Effects of Implants. . . . . . . . . . . . . . . . . . . . . . . . . . .. 234 10.3. Blood Compatibility ......................................... 236 10.3.1. Factors Affecting Blood Compatibility. . . . . . . . . . . . . . . . . .. 237 10.3.2. Nonthrombogenic Surfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 238 10.4. Carcinogenicity.............................................. 240 10.4.1. Testing of Carcinogenicity. . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 240 10.4.2. Risk Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 241 Problems ........................................................ 242 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 243 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 244 Chapter 11 • SOFT TISSUE REPLACEMENT I: SUTURES, SKIN, AND MAXILLOFACIAL IMPLANTS........... 245 11.1. Sutures, Surgical Tapes, and Adhesives. . . . . . . . . . . . . . . . . . . . . . . .. 246 11.1.1. Sutures .............................................. 246 11.1.2. Surgical Tapes and Staples. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 248 11.1.3. Tissue Adhesives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 248 11.2. Percutaneous and Skin Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 250 11.2.1. Percutaneous Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 250 11.2.2. Artificial Skins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 253 11.3. Maxillofacial and Other Soft-Tissue Augmentation. . . . . . . . . . . . . .. 255 11.3.1. Maxillofacial Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 255 11.3.2. Ear and Eye Implants ................................. 256 11.3.3. Fluid Transfer Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 258 11.3.4. Space-Filling Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 259 Problems ........................................................ 262 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 263 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 264 Chapter 12 • SOFT TISSUE REPLACEMENT II: BLOOD-INTERFACING IMPLANTS 265 12.1. Vascular Implants ........................................... 265 12.2. Heart Valve Implants ........................................ 272 12.3. Heart and Lung Assist Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 275 xii CONTENTS 12.4. Artificial Organs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 278 12.4.1. Artificial Hearts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 279 12.4.2. Cardiac Pacemaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 279 12.4.3. Artificial Kidney Dialysis Membrane .................... 283 Problems ........................................................ 289 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 290 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 291 Chapter 13 • HARD TISSUE REPLACEMENT I: LONG BONE REPAIR............................. 293 13.1. Wires, Pins, and Screws. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 295 13.1.1. Wires................................................ 295 13.1.2. Pins................................................. 296 13.1.3. Screws............................................... 296 13.2. Fracture Plates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 300 13.2.1. Cortical Bone Plates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 300 13.2.2. Cancellous Bone Plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 302 13.3. Intramedullary Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 306 13.4. Spinal Fixation Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 310 13.5. Fracture Healing by Electrical and Electromagnetic Stimulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 311 Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 314 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 315 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 316 Chapter 14 • HARD TISSUE REPLACEMENT II: JOINTS AND TEETH.............................. 317 14.1. Joint Replacements........... . .... ...... . ........ . ... . .... .. 317 14.1.1. Lower Extremity Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 319 14.1.2. Upper Extremity Implants.............................. 331 14.2. Dental Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 339 14.2.1. Endosseous Tooth Implants. . . . . . . . . . . . . . . . . . . . . . . . . . .. 339 14.2.2. Subperiosteal and Staple/Transosteal Implants. . . . . . . . . . .. 343 14.3. Interface Problems in Orthopedic Implants ..................... 344 14.3.1. Bone Cement Fixation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 346 14.3.2. Porous Ingrowth (Biological) Fixation. . . . . . . . . . . . . . . . . .. 347 14.3.3. Direct Bonding between Bone and Implant. . . . . . . . . . . . . .. 351 14.3.4. Interference and Passive Fixation ....................... 351 Problems ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 352 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 352 Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 352