BIOMATERIALS SCIENCE This page intentionally left blank BlOMATERIALS SCIENCE An Introduction to Materials in Medicine Edited by Buddy D. Ratner and Allan S. Hoffman Center for Bioengineering and Department of Chemical Engineering University of Washington Seattle, Washington Frederick J. Schoen Department of Pathology Brigham and Women's Hospital and Harvard Medical School Boston, Massachusetts Jack E. Lemons Departments of Biomaterials and Surgery School of Dentistry and Medicine University of Alabama at Birmingham Birmingham, Alabama Academic Press San Diego London Boston New York Sydney Tokyo Toronto Cover photographs: Background is detail of grains in cold-worked 316L stainless steel showing evidence of plastic deformation. (See Chapter 2.2, courtesy of Zimmer USA, Warsaw, IN.) Inset is cardiac pacemaker with polyurethane lead tine and connector. (See Chapter 6.2, courtesy of Medtronic, Inc.) This book is printed on acid-free paper, Copyright © 1996 by ACADEMIC PRESS All Rights Reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publisher. Academic Press a division of Harcourt Brace & Companv 525 B Street, Suite 1900, San Diego, California 92101-4495, USA http://www.apnet.com Academic Press Limited 24-28 Oval Road, London NW1 7DX, UK http://www.hbuk.co.uk/ap/ Library of Congress Cataloging-in-Publication Data Biomaterials science : an introduction to materials in medicine / edited by Buddy D. Ratner ... [et al.]. p. cm. Includes index. ISBN 0-12-582460-2 (case: alk. paper) ISBN 0-12-582461-0 (paperback: alk. paper) 1. Biomedical materials. I. Ratner, B. D. (Buddy D.). date. R857.M3B5735 1996 610'.28-dc20 96-19088 CIP PRINTED IN THE UNITED STATES OF AMERICA 01 02 EB 9 8 7 6 5 CONTENTS Contributors ix 2.6 Ceramics, Glasses, and Glass-Ceramics 73 Preface xi LARRY L. HENCH Biomaterials Science.- An Interdisciplinary 2.7 Nafural Materjals 84 Endeavor IOANNIS v. YANNAS BUDDY D. RATNER 1 2.8 Composites 94 HAROLD ALEXANDER PART I MATERIALS SCIENCE AND 2.9 Thin Films, Grafts, and Coatings 105 ENGINEERING BUDDY D. RATNER AND ALLAN S. HOFFMAN CHAPTER 1 Properties of Materials 2.10 Fabrics 118 SHALABY W. SHALABY 1.1 Introduction 11 JACK E. LEMONS 2.11 Biologically Functional Materials 124 ALLAN S. HOFFMAN 1.2 Bulk Properties of Materials 11 FRANCIS W. COOKE PART II 1.3 Surface Properties of Materials 21 PART II BUDDY D RATNER BIOLOGY, BIOCHEMISTRY, CHAPTER 2 Classes of Materials Used in Medicine AND MEDICINE 2.1 Introduction 37 CHAPTERS Some Background Concepts ALLAN S. HOFFMAN 3.1 Introduction 133 BUDDY D. RATNER 2.2 Metals 37 JOHN B. BRUNSKI 3.2 Proteins: Structure, Properties, and Adsorption 2.3 Polymers 50 to Surfaces 133 SUSAN A. V1SSER, ROBERT W. HERGENROTHER, THOMAS A. HORBETT AND STUART L. COOPER 3.3 Cells: Their Surfaces and Interactions with 2.4 Hydrogels 60 Materials 141 NIKOLAOS A. PF.PPAS JEFF M. SCHAKENRAAD 2.5 Bioresorbable and Bioerodible Materials 64 3.4 Tissues 147 JOACHIM KOHN AND ROBERT LANGER FREDERICK J. SCHOEN V vi CONTENTS CHAPTER 4 Host Reactions to Biomaterials and Their Evaluation 4.1 Introduction 165 FREDERICK .). SCHOEN 4.2 Inflammation, Wound Healing, and the Foreign Body Response 165 JAMES M. ANDERSON 4.3 Immunology and the Complement System 173 RICHARD J. JOHNSON 4.4 Systemic Toxicity and Hypersensitivity 188 KATHARINE MERRITT 4.5 Blood Coagulation and Blood—Materials Interactions 193 STEPHEN R. HANSON AND LAURENCE A. HARKER 4.6 Tumorigenesis and Biomaterials 200 FREDERICK J. SCHOEN 4.7 implant-Associated Infection 205 ANTHONY G. GRISTINA AND PAUL T. NAYLOR CHAPTER 5 Testing Biomaterials 5.1 Introduction 215 BUDDY D. RATNER 6.4 Mechanical Breakdown in the Biological Environment 267 CARL R. McMILLIN 6.5 Pathologic Calcification of Biomaterials 272 YASHWANT PATHAK, FREDERICK J. SCHOEN, AND ROBERT J. LEVY CHAPTER 7 Application of Materials in Medicine and Dentistry 7.1 Introduction JACK E. LEMONS 7.2 Cardiovascular Applications PAUL DIDISHEIM AND JOHN T. WATSON 283 283 7.3 Nonthrombogenic Treatments and Strategies 297 SUNG WAN KIM 7.4 Dental Implants JACK E. LEMONS 7.5 Adhesives and Sealants DENNIS C. SMITH 7.6 Ophthalmologic Applications MIGUEL F. REFOJO 7.7 Orthopedic Applications J. LAWRENCE KATZ 308 319 328 335 5.2 In Vitro Assessment of Tissue Compatibility SHARON I. NORTHUP 215 7.8 Drug Delivery Systems JORGE HELLER 346 5.3 In Vivo Assessment of Tissue Compatibility 220 MYRON SPECTOR AND PEGGY A. LALOR 5.4 Testing of Blood—Materials interactions 228 STEPHEN HANSON AND BUDDY D. RATNER 5.5 Animal Models 238 BRAD H. VALE, JOHN E. WILLSON, AND STEVEN M. NIEMI CHAPTER 6 Degradation of Materials in the Biological Environment 6.1 Introduction 243 BUDDY D. RATNER 6.2 Chemical and Biochemical Degradation of Polymers 243 ARTHUR J. COURY 6.3 Degradative Effects of the Biological Environment on Metals and Ceramics 260 DAVID F, WILLIAMS AND RACHEL L, WILLIAMS 7.9 Sutures DENNIS GOUPIL 356 7.10 Burn Dressings 360 JEFFREY B. KANE, RONALD G. TOMPK1NS, MARTIN L. YARMUSH, AND JOHN F. BURKE 7.11 Bioelectrodes LOIS S. ROBBLEE AND JAMES D. SWEENEY 7.12 Biomedical Sensors and Biosensors PAUL YAGER CHAPTER 8 Artificial Organs 8.1 Introduction FREDERICK J. SCHOEN 8.2 Implantable Pneumatic Artificial Hearts KEVIN D. MURRAY AND DON B. OLSEN 8.3 Extracorporeal Artificial Organs PAUL S. MALCHESKY 371 375 389 389 400 CONTENTS vii PACT III 9.7 Correlations of Material Surface Properties with PRACTICAL ASPECTS Biological Responses OF B1OMATER1ALS 9.8 Implant Retrieval and Evaluation 451 CHAPTER 9 Implants and Devices • JAMES M. ANDERSON CHAPTER 9 Implants and Devices CHAPTER 10 New Products and Standards 9.1 Introduction 415 FREDERICK J. SCHOEN 10.1 Introduction 457 JACK E. LEMONS 9.2 Sterilization of Implants 415 JOHN B. KOWALSKI AND ROBERT F. MORRISSEY 10.2 Voluntary Consensus Standards 457 STANLEY A. BROWN 9.3 Cardiovascular Implantation 420 10.3 Product Development and Regulation 461 LINDA M. GRAHAM, DIANA WHITTLESEY, AND BRIAN BEVACQUA NANCY B MATED 9.4 Dental Implantation 426 A. NORMAN CRANIN, ARAM SIRAKIAN, AND MICHAEL KLEIN CHAPTER 11 Perspectives and Possibilities in Biomaterials Science BUDDY D. RATNER 465 9.5 Ophthalmic Implantation 435 STEPHEN A. OBSTBAUM APPENDIX Properties of Biological Fluids STEVEN M. SLACK 469 9.6 Implant and Device Failure 443 ALLAN S, HOFFMAN Index 473 This page intentionally left blank CONTRIBUTORS Numbers in parentheses indicate the pages on which the au- Laurence A. Marker (193) Division of Hematology—Oncology, thors' contributions begin. Emory University School of Medicine, Atlanta, Georgia 30322 Harold Alexander (94) Department of Bioengineering, Hospi- tal for Joint Diseases Orthopaedic Institute, New York, New Jorge Heller (346) Advanced Polymer Systems Research Insti- York 10003 tute, Redwood City, California 94063 James M. Anderson (165, 451) Institute of Pathology, Case LarrY L.Hench (73) Department of Materials Science and Western Reserve University, Cleveland, Ohio 44106 Engineering, University of Florida, Gainesville, Florida 32611 Brian Bevacqua (420) Case Western Reserve University School of Medicine and Anesthesia Service, Veterans Affairs Medi- Robert W. Hergenrother (50) Target Therapeutics, Inc., Free- cal Center, Cleveland, Ohio 44106 mont, California 94537 Stanley A. Brown (457) Food and Drug Administration, Center Allan S.Hoffman (37, 105, 124, 443) Center for Bioengineer- for Devices and Radiological Health, Office of Science and ing and Department of Chemical Engineering, University of Technology, Division of Mechanics and Materials Science, Washington, Seattle, Washington 98195 Rockville, Maryland 20852 Thomas A. Horbett (133) Center for Bioengineering and De- John B, Brunski (37) Department of Biomedical Engineering, partment of Chemical Engineering, University of Washing- Rensselaer Polytechnic Institute, Troy, New York 12180 ton, Seattle, Washington 98195 John F. Burke (360) Massachusetts General Hospital, Harvard Richard J. Johnson (173) Baxter Healthcare Corporation, Medical School, Boston, Massachusetts 02114 Round Lake, Illinois 60073 Francis W, Cooke (11) Orthopaedic Research Institute, Wich- Jeffrey B. Kane (360) Massachusetts General Hospital, Har- ita, Kansas 67214 vard Medical School, Boston, Massachusetts 02114 Stuart L. Cooper (50) College of Engineering, University of J. Lawrence Katz (335) Department of Biomedical Engineering, Delaware, Newark, Delaware 19716 Case Western Reserve University, Cleveland, Ohio 44106 Arthur J. Coury (243) Focal, Inc., Lexington, Massachusetts Michael Klein (426) Department of Dental and Oral Surgery, 02173 Brookdale University Hospital and Medical Center, The A. Norman Cranin (426) Department of Dental and Oral Sur- Dental Implant Group, Brooklyn, New York 11212 gery, Brookdale University Hospital and Medical Center, Joachim Kohn (64) Department of Chemistry, Wright and The Dental Implant Group, Brooklyn, New York 11212 Rieman Laboratories, Rutgers University, Piscataway, New Paul Didisheim (283) Bioengineering Research Group, Division Jersey 08855 of Heart and Vascular Diseases, National Heart, Lung, and John B. Kowalski (415) Johnson & Johnson, Sterilization Sci- Blood Institute, Bethesda, Maryland 20892 ence & Technology, New Brunswick, New Jersey 08906 Dennis Goupil (356) Datascope Corporation, Fairfield, New Peggy A. Lalor (220) Howmedica, Inc., Rutherford, Newjer- Jersey 07004 sey 07070 Linda M. Graham (420) Division of Vascular Surgery, Case Robert Langer (64) Department of Chemical Engineering, Mas- Western Reserve University School of Medicine and Vascular sachusetts Institute of Technology, Cambridge, Massachu- Surgery Section, Veterans Affairs Medical Center, Cleveland, setts 02139 Ohio 44106 Jack E.Lemons (11, 283, 308, 457) Departments of Biomateri- Anthony G, Gristina (205) Medical Sciences Research Institute, als and Surgery, School of Dentistry and Medicine, Univer- an affiliate of George Mason University, Herndon, Vir- sity of Alabama at Birmingham, Birmingham, Alabama ginia 22070 35294 Stephen R. Hanson (193, 228) Division of Hematology- Robert J. Levy (272) Department of Pediatrics, and Communi- Oncology, Emory University School of Medicine, Atlanta, cable Diseases and Pharmaceutics, University of Michigan, Georgia 30322 Ann Arbor, Michigan 48109 ix