Table Of ContentBIOMATERIALS 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
means, electronic or mechanical, including photocopy, recording, or any information
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Academic Press
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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
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
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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
