Biomaterials science: an introduction to materials in medicine

497 Pages·1996·39.573 MB·English

by  Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons

BIOMATERIALS SCIENCE
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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
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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
PART I HAROLD ALEXANDER
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 6.4 Mechanical Breakdown in the Biological
Environment 267
Their Evaluation
CARL R. McMILLIN
4.1 Introduction 165
6.5 Pathologic Calcification of Biomaterials 272
FREDERICK .). SCHOEN
YASHWANT PATHAK, FREDERICK J. SCHOEN, AND ROBERT J. LEVY
4.2 Inflammation, Wound Healing, and the Foreign
CHAPTER 7 Application of Materials in Medicine
Body Response 165
and Dentistry
JAMES M. ANDERSON
7.1 Introduction 283
4.3 Immunology and the Complement System 173
JACK E. LEMONS
RICHARD J. JOHNSON
7.2 Cardiovascular Applications 283
4.4 Systemic Toxicity and Hypersensitivity 188 PAUL DIDISHEIM AND JOHN T. WATSON
KATHARINE MERRITT
7.3 Nonthrombogenic Treatments and Strategies 297
4.5 Blood Coagulation and Blood—Materials SUNG WAN KIM
Interactions 193
STEPHEN R. HANSON AND LAURENCE A. HARKER 7.4 Dental Implants 308
JACK E. LEMONS
4.6 Tumorigenesis and Biomaterials 200
FREDERICK J. SCHOEN 7.5 Adhesives and Sealants 319
DENNIS C. SMITH
4.7 implant-Associated Infection 205
ANTHONY G. GRISTINA AND PAUL T. NAYLOR 7.6 Ophthalmologic Applications 328
MIGUEL F. REFOJO
CHAPTER 5 Testing Biomaterials
7.7 Orthopedic Applications 335
5.1 Introduction 215
J. LAWRENCE KATZ
BUDDY D. RATNER
7.8 Drug Delivery Systems 346
5.2 In Vitro Assessment of Tissue Compatibility 215
JORGE HELLER
SHARON I. NORTHUP
7.9 Sutures 356
5.3 In Vivo Assessment of Tissue Compatibility 220
DENNIS GOUPIL
MYRON SPECTOR AND PEGGY A. LALOR
7.10 Burn Dressings 360
5.4 Testing of Blood—Materials interactions 228
JEFFREY B. KANE, RONALD G. TOMPK1NS, MARTIN L. YARMUSH,
STEPHEN HANSON AND BUDDY D. RATNER
AND JOHN F. BURKE
5.5 Animal Models 238
7.11 Bioelectrodes 371
BRAD H. VALE, JOHN E. WILLSON, AND STEVEN M. NIEMI
LOIS S. ROBBLEE AND JAMES D. SWEENEY
CHAPTER 6 Degradation of Materials in the
7.12 Biomedical Sensors and Biosensors 375
Biological Environment
PAUL YAGER
6.1 Introduction 243
CHAPTER 8 Artificial Organs
BUDDY D. RATNER
8.1 Introduction 389
6.2 Chemical and Biochemical Degradation of FREDERICK J. SCHOEN
Polymers 243
ARTHUR J. COURY 8.2 Implantable Pneumatic Artificial Hearts 389
KEVIN D. MURRAY AND DON B. OLSEN
6.3 Degradative Effects of the Biological Environment
on Metals and Ceramics 260 8.3 Extracorporeal Artificial Organs 400
DAVID F, WILLIAMS AND RACHEL L, WILLIAMS PAUL S. MALCHESKY
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
CCHHAAPTPERT ER9 9 ImIpmlanpts lanatnsd anDedvi ceDs ev•i ces JAMES M. ANDERSON
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
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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