Biomaterials Science Second Edition An Introduction to Materials in Medicine

Biomaterials Science Second Edition An Introduction to Materials in Medicine

(Parte 1 de 12)

An Introduction to

Materials in Medicine 2nd Edition

Edited by

Buddy D. Ratner, Ph.D.

Professor, Bioengineering and Chemical Engineering

Director of University of Washington Engineered Biomaterials (UWEB), an

NSF Engineering Research Center University of Washington, Seattle, WA USA

Allan S. Hoffman, ScD.

Professor of Bioengineering and Chemical Engineering

UWEB Investigator University of Washington, Seattle, WA USA

Frederick J. Schoen, M.D., Ph.D.

Professor of Pathology and Health Sciences and Technology (HST)

Harvard Medical School

Executive Vice Chairman, Department of Pathology

Brigham and Women’s Hospital Boston, MA USA

Jack E. Lemons, Ph.D.

Professor and Director of Biomaterials Laboratory Surgical Research

Departments of Prosthodontics and Biomaterials, Orthopaedic Surgery/Surgery and

Biomedical Engineering, Schools of Dentistry, Medicine and Engineering University of Alabama at Birmingham, AL USA

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Library of Congress Cataloging-in-Publication Data

Buddy D. Ratner[et al.].– 2nd ed.

Biomaterials science : an introduction to materials in medicine / edited by p. ; cm.

Includes bibliographical references and index. ISBN 0-12-582463-7 (hardcover : alk. paper) 1. Biomedical materials. [DNLM: 1. Biocompatible Materials. QT 37 B6145 1996] I. Ratner, B. D. (Buddy D.), 1947- R857.M3B5735 2004 610′.28–dc22 2003027823

British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library

ISBN: 0-12-582463-7

For all information on all Academic Press publications visit our Web site at w.academicpress.com

Editors and Lead Contributors ix Preface xi

Biomaterials Science: A Multidisciplinary Endeavor 1

A History of Biomaterials 10 BUDDY D. RATNER

CHAPTER 1 Properties of Materials

1.1 Introduction 23 JACK E. LEMONS

1.2 Bulk Properties of Materials 23 FRANCIS W. COOKE

1.3 Finite Element Analysis 32 IVANVESELYANDEVELYNOWENCAREW

1.4 Surface Properties and Surface

Characterization of Materials 40 BUDDY D. RATNER

1.5 Role of Water in Biomaterials 59 ERWIN A. VOGLER

CHAPTER 2 Classes of Materials Used in Medicine

2.1 Introduction 67 ALLAN S. HOFFMAN

2.3 Silicone Biomaterials: History and Chemistry 80 ANDRÉ COLAS AND JIM CURTIS

2.4 Medical Fibers and Biotextiles 86 STEVEN WEINBERG AND MARTIN W. KING

2.5 Hydrogels 100 NICHOLAS A. PEPPAS

2.6 Applications of “Smart Polymers” as

Biomaterials 107 ALLAN S. HOFFMAN

2.7 Bioresorbable and Bioerodible Materials 115 JOACHIMKOHN,SASCHAABRAMSON,ANDROBERTLANGER

2.8 Natural Materials 127 IOANNIS V. YANNAS

2.9 Metals 137 JOHN B. BRUNSKI

2.10 Ceramics, Glasses, and Glass-Ceramics 153 LARRY L. HENCH AND SERENA BEST

2.1 Pyrolytic Carbon for Long-Term Medical

Implants 170 ROBERT B. MORE, AXEL D. HAUBOLD, AND JACK C. BOKROS

2.12 Composites 181 CLAUDIO MIGLIARESI AND HAROLD ALEXANDER

2.13 Nonfouling Surfaces 197 BUDDYD.RATNERANDALLANS.HOFFMAN vi CONTENTS

2.14 Physicochemical Surface Modification of Materials Used in Medicine 201 BUDDYD.RATNERANDALLANS.HOFFMAN

2.15 Textured and Porous Materials 218 JOHN A. JANSEN AND ANDREAS F. VON RECUM

2.16 Surface-Immobilized Biomolecules 225 ALLAN S. HOFFMAN AND JEFFREY A. HUBBELL

CHAPTER 3 Some Background Concepts

3.1 Background Concepts 237 BUDDY D. RATNER

3.2 The Role of Adsorbed Proteins in Tissue

Response to Biomaterials 237 THOMASA.HORBETT

3.3 Cells and Cell Injury 246 RICHARD N. MITCHELL AND FREDERICK J. SCHOEN

3.4 Tissues, the Extracellular Matrix, and

Cell–Biomaterial Interactions 260 FREDERICK J. SCHOEN AND RICHARD N. MITCHELL

3.5 Mechanical Forces on Cells 282 LARRY V. MCINTIRE, SUZANNE G. ESKIN, AND ANDREW YEE

CHAPTER 4 Host Reactions to Biomaterials and Their Evaluation

4.1 Introduction 293 FREDERICK J. SCHOEN

4.2 Inflammation, Wound Healing, and the

Foreign-Body Response 296 JAMES M. ANDERSON

4.3 Innate and Adaptive Immunity: The Immune

Response to Foreign Materials 304 RICHARD N. MITCHELL

4.4 The Complement System 318 RICHARD J. JOHNSON

4.5 Systemic Toxicity and Hypersensitivity 328 ARNE HENSTEN-PETTERSEN AND NILS JACOBSEN

4.6 Blood Coagulation and Blood–Materials

Interactions 332 STEPHEN R. HANSON

4.7 Tumorigenesis and Biomaterials 338 FREDERICK J. SCHOEN

4.8 Biofilms, Biomaterials, and Device-Related

Infections 345 BILL COSTERTON, GUY COOK, MARK SHIRTLIFF,

CHAPTER 5 Biological Testing of Biomaterials

5.1 Introduction to Testing Biomaterials 355 BUDDY D. RATNER

5.2 In Vitro Assessment of Tissue

Compatibility 356 SHARON J. NORTHUP

5.3 In Vivo Assessment of Tissue

Compatibility 360 JAMES M. ANDERSON AND FREDERICK J. SCHOEN

5.4 Evaluation of Blood-Materials Interactions 367 STEPHEN R. HANSON AND BUDDY D. RATNER

5.5 Large Animal Models in Cardiac and

Vascular Biomaterials Research and Testing 379

5.6 Microscopy for Biomaterials Science 396 KIP D. HAUCH

CHAPTER 6 Degradation of Materials in the Biological Environment

6.1 Introduction: Degradation of Materials in the

Biological Environment 411 BUDDY D. RATNER

6.2 Chemical and Biochemical Degradation of

Polymers 411 ARTHUR J. COURY

6.3 Degradative Effects of the Biological

Environment on Metals and Ceramics 430 DAVID F. WILLIAMS AND RACHEL L. WILLIAMS

6.4 Pathological Calcification of Biomaterials 439 FREDERICK J. SCHOEN AND ROBERT J. LEVY

CONTENTS vii

CHAPTER 7 Application of Materials in Medicine, Biology, and Artificial Organs

7.1 Introduction 455 JACK E. LEMONS AND FREDERICK J. SCHOEN

7.2 Nonthrombogenic Treatments and Strategies 456 MICHAEL V. SEFTON AND CYNTHIA H. GEMMELL

7.3 Cardiovascular Medical Devices 470 ROBERT F. PADERA, JR., AND FREDERICK J. SCHOEN

7.4 Implantable Cardiac Assist Devices 494 WILLIAM R. WAGNER, HARVEY S. BOROVETZ,

7.5 Artificial Red Blood Cell Substitutes 507 THOMASMINGSWICHANG

7.6 Extracorporeal Artificial Organs 514 PAUL S. MALCHESKY

7.7 Orthopedic Applications 527 NADIM JAMES HALLAB, JOSHUA J. JACOBS,

7.8 Dental Implantation 556 A.NORMANCRANINANDJACKE.LEMONS

7.9 Adhesives and Sealants 573 DENNIS C. SMITH

7.10 Ophthalmological Applications 584 MIGUEL F. REFOJO

7.1 Intraocular Lens Implants: A Scientific

Perspective 592 ANIL S. PATEL

7.12 Burn Dressings and Skin Substitutes 603

7.13 Sutures 615 MARKS.ROBYANDJACKKENNEDY

7.14 Drug Delivery Systems 629 JORGE HELLER AND ALLAN S. HOFFMAN

7.15 Bioelectrodes 649 RAMAKRISHNAVENUGOPALANANDRAYIDEKER

7.16 Cochlear Prostheses 658 FRANCIS A. SPELMAN

7.17 Biomedical Sensors and Biosensors 670 PAUL YAGER

7.18 Diagnostics and Biomaterials 685 PETER J. TARCHA AND THOMAS E. ROHR

7.19 Medical Applications of Silicones 698 JIM CURTIS AND ANDRÉ COLAS

CHAPTER 8 Tissue Engineering

8.1 Introduction 709 FREDERICK J. SCHOEN

8.2 Overview of Tissue Engineering 712 SIMON P. HOERSTRUP AND JOSEPH P. VACANTI

8.3 Immunoisolation 728 MICHAEL J. LYSAGHT AND DAVID REIN

8.4 Synthetic Bioresorbable Polymer Scaffolds 735 ANTONIOS G. MIKOS, LICHUN LU, JOHNNA S. TEMENOFF,

CHAPTER 9 Implants, Devices, and Biomaterials: Issues Unique to this Field

9.1 Introduction 753 FREDERICK J. SCHOEN

9.2 Sterilization of Implants and Devices 754 JOHN B. KOWALSKI AND ROBERT F. MORRISSEY

9.3 Implant and Device Failure 760 FREDERICK J. SCHOEN AND ALLAN S. HOFFMAN

9.4 Correlation, Surfaces and Biomaterials

Science 765 BUDDY D. RATNER

9.5 Implant Retrieval and Evaluation 771 JAMES M. ANDERSON, FREDERICK J. SCHOEN,

CHAPTER 10 New Products and Standards

10.1 Introduction 783 JACK E. LEMONS

10.2 Voluntary Consensus Standards 783 JACK E. LEMONS

10.3 Development and Regulation of Medical

Products Using Biomaterials 788 ELAINE DUNCAN viii CONTENTS

10.4 Ethical Issues in the Development of

New Biomaterials 793 SUBRATASAHAANDPAMELASAHA

10.5 Legal Aspects of Biomaterials 797 JAY P. MAYESH AND MARY F. SCRANTON

CHAPTER 1 Perspectives and Possibilities in

Biomaterials Science 805 BUDDY D. RATNER, FREDERICK J. SCHOEN, JACK E. LEMONS, AND ALLAN S. HOFFMAN

APPENDIX A Properties of Biological Fluids 813 STEVEN M. SLACK

APPENDIX B Properties of Soft Materials 819 CRISTINA L. MARTINS

APPENDIX C Chemical Compositions of Metals

Used for Implants 823 JOHN B. BRUNSKI

APPENDIX D The Biomaterials Literature 825 Index 831

Numbers in parentheses indicate the pages on which the authors’ contributions begin.

Harold Alexander (180) Orthogen Corporation, Springfield, NJ 07081

James M. Anderson (296, 360, 771) Institute of Pathology, Case Western Reserve University, Cleveland, OH 44106

Richard W. Bianco (379) Division of Experimental Surgery,

DepartmentofSurgery, UniversityofMinnesota, Minneapolis, MN 55455

John B. Brunski (137, 823) Department of Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY 12180

ThomasM.S.Chang(507)ArtificialCellsandOrganResearch

Centre, McGill University, Montreal, Quebec H3G 1Y6, Canada

AndérColas(80, 697)DowCorningLifeSciences, B-7180Seneffe, Belgium

Francis W. Cooke (23) Orthopedic Research Institute, Wichita, KS 67214

Stuart L. Cooper (67) Ohio State University, Department of Chemical Engineering, Raleigh, Columbia, OH 43210

Joachim Kohn (115) Department of Chemistry, Rutgers, The State University of New Jersey, Piscataway, NJ 08854

Bill Costerton (345) Center for Biofilm Engineering, College of Engineering, Montana State University, Bozeman, MT 59717

Arthur J. Coury (411) Biomaterials Research, Genzyme Corporation, Cambridge, MA 02139

A. Norman Cranin (5) Brookdale University Hospital and

Medical Center, The Dental Implant Group, Brooklyn, NY 11212

Jim Curtis (80, 697) Life Sciences Industry, Medical Device Operations,DowCorningCorporation,Midland,MI48686

Elaine Duncan (788) Paladin Medical, Stillwater, MN 55082

NadimJamesHallab(526)DepartmentofOrthopedicSurgery, Rush Medical College, Chicago, IL 60612

StephenR.Hanson(328, 367)DepartmentofBiomedicalEngineering, Oregon Health Sciences University, Beaverton, OR 97006

Kip D. Hauch (396) Department of Chemical Engineering, University of Washington, Seattle, WA 98195

Jorge Heller (628) A.P. Pharma, Department of Research, Redwood City, CA 94063

Larry L. Hench (153) Department of Materials, Imperial

College of Science, Technology and Medicine, University of London, London SW7 2BP, United Kingdom

Arne Hensten-Pettersen (328) Scandinavian Institute of Dental Materials (NIOM), Haslum, Norway

Simon P. Hoerstrup (712) Clinic for Cardiovascular Surgery, University Hospital, CH8091, Zurich, Switzerland

Department of Bioengineering, University of Washington, Seattle, WA 98195

Thomas A. Horbett (234) Center for Bioengineering and

Department of Chemical Engineering, University of Washington, Seattle, WA 98195

John A. Jansen (218) Department of Biomaterials, Dental

School, University of Nijmegen, 6500 HB, Nijmegen, The Netherlands

Richard J. Johnson (318) Exploratory Research, Baxter Healthcare Coporation, Round Lake, IL 60073

John B. Kowalski (754) Sterilization Science & Technology, Johnson & Johnson, New Brunswick, NJ 08906

Jack E. Lemons (1, 23, 455, 783, 805) Department of Biomaterials and Surgery, School of Dentistry and Medicine, University of Alabama, Birmingham, AL 35294

Michael J. Lysaght (728) Center for Biomedical Engineering, Brown University, Providence, RI 02912

Paul S. Malchesky (514) International Center for Artificial Organs and Transplantation, Painesville, OH 44077

Cristina L. Martins (819) INEB-Instituto de Engenharia

Biomédica, Laboratório de Biomateriais, Universidade do Porto, 4150-180 Porto, Portugal

Jay P. Mayesh (797) Kaye, Scholer, LLP, New York, NY 10022

Larry V. McIntire (282) Department of Bioengineering,

Institute of Bioscience & Bioengineering, Rice University, Houston, TX 77005 x EDITORS AND LEAD CONTRIBUTORS

Claudio Migliaresi (181) Department of Materials Engineering and Industrial Technologies, University of Trento, 38050 Trento, Italy

Antonios G. Mikos (735) Department of Bioengineering, Rice University, Houston, TX 77251

Richard N. Mitchell (246, 260, 304) Department of Pathology, Brigham and Women’s Hospital, Boston, MA 02115

Robert B. More (170) Medical Carbon Research Institute, Austin, TX 78754

Jeffrey R. Morgan (602) Department of Molecular Pharmacology, Physiology, and Biotechnology, Biomedical Center, Providence, RI 02912

Sharon J. Northup (356) Northup RTS, Highland Park, IL 60035

Robert F. Padera, Jr. (470) Department of Pathology, Brigham and Women’s Hospital, Boston, MA 02115

Anil S. Patel (591) Alcon Labs, Seattle, WA 98115

Nicholas A. Peppas (100) Department of Chemical Engineering, The University of Texas at Austin, Austin, TX 78712

Buddy D. Ratner (1, 10, 40, 197, 201, 237, 355, 367, 411, 803) University of Washington Engineered Biomaterials, University of Washington, Seattle, WA 98195

Miguel F. Refojo (583) Department of Opthalmology, The

Schepens Eye Research Institute, Harvard Medical School, Boston, MA 02114

Mark S. Roby (614) United States Surgical, North Haven, CT 06473

Subrata Saha (793) Biomedical Engineering Science Program, Alfred University, Alfred, NY 14802

Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115

Michael V. Sefton (456) Institute of Biomaterials and Biomedical, UniversityofToronto, Toronto, ONM533G9, Canada

Steven M. Slack (813) Department of Biomedical Engineering, University of Memphis, Memphis, TN 38152

Dennis C. Smith (572) Centre for Biomaterials, University of Toronto, Toronto, ON L9Y 3Y9, Canada

Francis A. Spelman (656)Advanced Cochlear Systems, Snoqualmie, WA. Department of Bioengineering, University of Washington, Seattle, WA 98195

Peter J. Tarcha (684) Abbott Laboratories, Department of Advanced Drug Delivery, Abbott Park, IL 60064

Ramakrishna Venugopalan (648) Codman and Shurtleff, A J&J Company, Raynham, MA 02767

Ivan Vesely (32) The Saban Research Institute of Children’s Hospital, Los Angeles, Los Angeles, CA 90027

Erwin A. Vogler (59) Department of Materials Science and

Engineering and Bioengineering, Materials Research Institute, Penn State University, University Park, PA 16802

William R. Wagner (454) Presbyterian University Hospital, University of Pittsburgh, Pittsburgh, PA 15219

Steven Weinberg (86) Biomedical Device Consultants and Laboratories, Inc., Webster, TX 77598

David F. Williams (430) Department of Clinical Engineering,

Royal Liverpool University Hospital, The University of Liverpool, Liverpool, L69 3BX, United Kingdom

Paul Yager (669) Department of Bioengineering, University of Washington, Seattle,WA 98195

(Parte 1 de 12)

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