B E D : H A IOMATERIALS NGINEERING AND EVICES UMAN PPLICATIONS V 1 OLUME Fundamentals and Vascular and Carrier Applications B E IOMATERIALS NGINEERING D : H A AND EVICES UMAN PPLICATIONS VOLUME 1 Fundamentals and Vascular and Carrier Applications Edited by Donald L. Wise, P D Joseph D. Gresser, P D H H Northeastern University Cambridge Scientific, Inc. Boston, MA Cambridge, MA Debra J. Trantolo, P D Mario V. Cattaneo, P D H H Cambridge Scientific, Inc. Cambridge Scientific, Inc. Cambridge, MA Cambridge, MA Kai-Uwe Lewandrowski, MD Michael J. Yaszemski, MD, P D H Massachusetts General Hospital Mayo Clinic Boston, MA Rochester, MN SPRINGER SCIENCE+BUSINESS MEDIA, LLC © 2000 Springer Science+Business Media New York Originally published by Humana Press Inc in 2000 Softcover reprint of the hardcover 1st edition 2000 All rights reserved. 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For those organizations that have been granted a photocopy license from the CCC, a separate system of payment has been arranged and is acceptable to Springer Scien ce+B usiness Media, LLC. 10 9 8 7 6 5 4 3 2 1 Library of Congress Cataloging-in-Publication Data Biomaterials engineeering and devices / edited by Donald L. Wise ... [et al.]. <v. ,1->p. cm. Includes bibliographical references and index. Contents: v. 1 Fundamentals and vascular and carrier applications -- v. 2 Orthopedic, dental, and bone graft applications. ISBN 978-1-61737-226-1 ISBN 978-1-59259-196-1 (eBook) DOI 10.1007/978-1-59259-196-1 1. Biomedical materials. 2. Biomedical engineering. I. Wise, Donald L. (Donald Lee), 1937- R857.M3 B5694 2000 610(cid:2).28--dc21 99-086203 The medical device and drug industries standards in analytical methodology and are consistently among the strongest techno- quality control. logical performers. Materials are a key The users of Biomaterials Engineering ingredient in their dynamic growth. Devel- and Devices: Human Applicationswill rep- opment of these materials is in a constant resent a broad base of backgrounds ranging state of activity, with the challenge of re- from the basic sciences (e.g., polymer placing old materials that cannot withstand chemistry and biochemistry) to more the tests of time, and the new materials’ applied disciplines (e.g., mechanical/ needs coming to the forefront in modern chemical engineering, orthopedics, and applications. This new reference text, pharmaceutics). To meet varied needs, each Biomaterials Engineering and Devices: chapter provides clear ancd fully detailed Human Applications, focuses on materials discussions. This in-depth, but practical, used in or on the human body—materials coverage should also assist recent induct- that define the world of “biomaterials.” ees to the biomaterials circle. The editors Biomaterials Engineering and Devices: trust that this reference textbook conveys Human Applications focuses on mate- the intensity of this fast moving field in an rials development and characterization. enthusastic presentation. Chapters deal with issues in the selection of Donald L. Wise, PHD proper biomaterials from biocompatibility to biostability to structure/function relation- Debra J. Trantolo, PHD Kai-Uwe Lewandrowski, MD ships. Chapters also focus on the use of specific biomaterials based on their physio- Joseph D. Gresser, PHD chemical and mechanical characterizations. Mario V. Cattaneo, PHD Integral to these chapters are discussions of Michael J. Yaszemski, MD, PHD v Contents Preface..................................................................................................................v Contributors ........................................................................................................ix About the Editors............................................................................................. xiii Contents of Volume 2........................................................................................xv PART1 COMPATIBILITYAND FUNCTIONALITY ISSUESIN APPLIED BIOMATERIALS 1 Molecular Mechanism of Biomaterial-Mediated Phagocyte Responses....................................3 Liping Tang 2 Hypersensitivity Associated with Metallic Biomaterials.........................15 Nadim Hallab, Joshua J. Jacobs, and Jonathan Black 3 Blood-Compatible Bioactive Polymers.....................................................25 Stéphane La Barre and Catherine Boisson-Vidal 4 Novel Modification Method of Bioprosthetic Tissue for Improved Calcification Resistance ................................................49 Ki Dong Park, Young Ha Kim, and Won Kyu Lee 5 Biocompatibility of Silicone Gel Breast Implants....................................57 Deepak V. Kilpadi and Dale S. Feldman 6 Endothelialization of Vascular Prostheses................................................85 Gary L. Bowlin, Steven P. Schmidt, Stanley E. Rittgers, and Kristin J. Pawlowski PART2 DESIGNAND EVALUATIONOF MATERIALSFOR VASCULAR APPLICATIONS 7 Collagen-Based Vascular Prostheses......................................................121 Jerome A. Werkmeister, Glenn A. Edwards, and John A. M. Ramshaw 8 Surface Modifications of Mechanical Heart Valves: Effects on Thrombogenicity................................................................137 Hoang S. Tran, Matthew M. Puc, Frank A. Chrzanowski, Jr., Charles W. Hewitt, David B. Soll, Bawa Singh, Nalin Kumar, Steven Marra, Vincent Simonetti, Jonathan Cilley, and Anthony J. DelRossi 9 The Importance of Radial Forces in Vascular Stent Design..................145 P. B. Snowhill, J. L. Nosher, and F. H. Silver 10 Blood Leak-Proof Porous Vascular Grafts.............................................161 Jin Ho Lee, Gilson Khang, and Hai Bang Lee 11 Formation of Neointima in Vascular Prosthesis Sealed with Autologous Adipose Tissue Fragments for Femoropopliteal Bypass ...181 Yukio Ichikawa, Yasuharu Noishiki, Tamitaro Soma, Ichiya Yamazaki, Takayuki Kosuge, and Norihisa Karube vii viii Contents 12 Clinical Improvement in Patients with Coronary and Peripheral Vascular Diseases Treated by LDL-Adsorption Using the Liposorber LA-15 System.................................................189 Tetsuzo Agishi and Bruce Gordon 13 Development of a New Hybrid Coronary Stent Design with Optimized Biocompatible Properties.........................................201 Armin Bolz, Claus Harder, Martin Unverdorben, and Max Schaldach PART3 BIOMATERIALSAS CARRIERSFOR BIOACTIVE AGENTS 14 Incorporation of Active Agent into Biodegradable Cement: Encapsulation of Agent as Protection from Chemical Degradation During Cure and Effect on Release Profile.................225 Joseph D. Gresser, Hisanori X. Nagaoka, Debra J. Trantolo, Pattisapu R. J. Gangadharam, Yung-Yueh Hsu, and Donald L. Wise 15 New Synthetic Degradable Polymers as Carrier Materials for BMP.....239 Kunio Takaoka, Shimpei Miyamoto, Naoto Saito, and Takao Okada 16 Use of Carrier Materials in Delivery of Bone Inductor Substances ......251 Philip J. Boyne 17 Preclinical and Clinical Evaluation of Osteogenic Protein-1 (BMP-7) in Bony Sites...............................267 Stephen D. Cook, Samantha L. Salkeld, Laura P. Patron, and David C. Rueger 18 Enzyme-Based Artificial Liver Support: A Computerized Expert System for Design, Optimization, and Operation Control................................................279 Serge Guzy, Samuel Sideman, and Noah Lotan 19 Bupivacaine Release from Biopolymeric Depots for the Alleviation of Postoperative Pain...........................................295 William A. Apruzzese, Joseph D. Gresser, Daniel B. Carr, Louis Shuster, Donald L. Wise, and Debra J. Trantolo 20 Biomaterial Implants for Treatment of Central Nervous System Diseases.................................................307 Wei Chen, Bingqing Ji, and D. Robert Lu Index.........................................................................................................335 Contributors TETSUZO AGISHI, MD, PHD • Kidney ANTHONY J. DELROSSI, MD • Department Center, Tokyo Women’s Medical of Surgery, Robert Wood Johnson University, Tokyo, Japan Medical School, Camden, NJ WILLIAM A. APRUZZESE, BA, MS • GLENN A. EDWARDS, DVSC • Department Department of Chemical of Veterinary Science, University Engineering, Northeastern of Melbourne, Werribee, Victoria, University, Boston, MA Australia JONATHAN BLACK, PHD• IMN DALE S. FELDMAN, PHD• Department Biomaterials Principle, King of Biomedical Engineering, of Prussia, PA The University of Alabama CATHERINE BOISSON-VIDAL, PHD• at Birmingham, Birmingham, AL Laboratoire de Recherches sur les PATTISAPU R. J. GANGADHARAM, PHD • Macromolécules (CNRS UMR Mycobacteriology Research 7540), Institut Galilée, Université Laboratory, University of Illinois Paris-Nord, Villetaneuse, France at Chicago, Chicago, IL PROF. DR. ARMIN BOLZ • Institute of BRUCE GORDON• The Rogosin Institute, Biomedical Engineering, University New York, NY of Karlsruhe, Karlsruhe, Germany JOSEPH D. GRESSER, PHD • Cambridge GARY L. BOWLIN, PHD• Department Scientific, Inc., Cambridge, MA of Biomedical Engineering, Virginia SERGE GUZY, PHD• Leonard and Diane Commonwealth University, Sherman Center for Research in Richmond, VA Biomaterials, Department PHILIP J. BOYNE, DMD, DSC • Oral and of Biomedical Engineering; Technion—Israel Institute Maxillofacial Surgery Service, of Technology, Haifa, Israel Loma Linda University Medical Center, Loma Linda, CA NADIM HALLAB, PHD • Department of Orthopedic Surgery, Rush- DANIEL B. CARR, MD • Tufts University Presbyterian St. Luke’s Medical School of Medicine, Boston, MA Center, Chicago, IL WEI CHEN, PHD• Department of Pharmaceutics, College DR. CLAUS HARDER • Biotronik GmbH, Erlangen, Germany of Pharmacy, University of Georgia, Athens, GA CHARLES W. HEWITT, PHD• Department of Surgery, Robert Wood Johnson FRANK A. CHRZANOWSKI, JR., MD • Medical School, Camden; Cooper Robert Wood Johnson Medical Health System/University Medical School, Camden; Cooper Health Center, Camden, NJ System/University Medical Center, YUNG-YUEH HSU • Cambridge Camden, NJ Scientific, Cambridge, MA JONATHAN CILLEY, MD•Department YUKIO ICHIKAWA, MD • First Department of Surgery, UMDNJ–Robert Wood of Surgery, Yokohama City University Johnson Medical School, Camden, NJ School of Medicine, Yokohama, Japan STEPHEN D. COOK, PHD • Department JOSHUA J. JACOBS, MD •Department of of Orthopaedic Surgery, Tulane Orthopedic Surgery, Rush- University School of Medicine, Presbyterian St. Luke’s Medical New Orleans, LA Center, Chicago, IL ix x Contributors BINGQING JI, PHD (CANDIDATE)• D. ROBERT LU, PHD • Department of Department of Pharmaceutics, College Pharmaceutics, College of Pharmacy, of Pharmacy, University of Georgia, University of Georgia, Athens, GA Athens, GA STEVEN MARRA, MD • Department NORIHISA KARUBE, MD • First Department of Surgery, Robert Wood Johnson of Surgery, Yokohama City University Medical School, Camden; Cooper School of Medicine, Yokohama, Japan Health System/University Medical GILSON KHANG, PHD•Department of Center, Camden, NJ Polymer Science and Technology, SHIMPEI MIYAMOTO, MD, PHD • Chonbuk National University, Department of Orthopedic Surgery, Chonju, Korea Osaka University Medical School, DEEPAK V. KILPADI, PHD, MBA • Depart- Osaka, Japan ment of Biomedical Engineering, HISANORI X. NAGAOKA, BA, BS • The University of Alabama Cambridge Scientific, Inc., at Birmingham, Birmingham, AL Cambridge, MA YOUNG HA KIM, PHD • Biomaterials YASUHARU NOISHIKI, MD, PHD• First Research Center, Korea Institute Department of Surgery, Yokohama of Science and Technology, City University School of Medicine, Cheongryang, Seoul, Korea Yokohama, Japan TAKAYUKI KOSUGE, MD, PHD • First J. L. NOSHER • Department of Radiology, Department of Surgery, Yokohama UMDNJ-Robert Wood Johnson City University School of Medicine, Medical School, Piscataway, NJ Yokohama, Japan TAKAO OKADA, PHD • Central Institute NALIN KUMAR, PHD• Medical Surface for Research, Taki Chemical Co. Ltd, Techniques, Mount Laurel, NJ Hyogo, Japan STÉPHANE LA BARRE, PHD• Laboratoire KI DONG PARK, PHD • Biomaterials de Recherches sur les Macromolécules Research Center, Korea Institute (CNRS UMR 7540), Institut Galilée, of Science and Technology, Université Paris-Nord, Villetaneuse, Cheongryang, Seoul, Korea France HAI BANG LEE, PHD • Biomaterials LAURA P. PATRON, BSE • Department of Orthopaedic Surgery, Tulane Laboratory, Korea Research Institute University School of Medicine, of Chemical Technology, Yusung, New Orleans, LA Taejon, Korea JIN HO LEE, PHD• Department of KRISTIN J. PAWLOWSKI, MS • Department of Biomedical Engineering, Virginia Polymer Science and Engineering, Commonwealth University, Hannam University, Ojeong Dong, Richmond, VA Daedeog Ku, Taejon, Korea WON KYU LEE, PHD • Biomaterials MATTHEW M. PUC, MD • Department of Surgery, Robert Wood Johnson Research Center, Korea Institute of Science and Technology, Medical School, Camden; Cooper Cheongryang, Seoul, Korea Health System/University Medical NOAH LOTAN, PHD • Leonard and Diane Center, Camden, NJ Sherman Center for Research JOHN A. M. RAMSHAW, PHD, DSC • in Biomaterials, Department of Division of Molecular Science, Biomedical Engineering; Technion— CSIRO, Parkville, Victoria, Australia Israel Institute of Technology, Haifa, STANLEY E. RITTGERS, PHD • Department Israel of Biomedical Engineering, The University of Akron, Akron, OH Contributors xi DAVID C. RUEGER, PHD• Creative DAVID B. SOLL, MD•Department BioMolecules Inc., Hopkinton, MA of Surgery, Robert Wood Johnson NAOTO SAITO, MD, PHD•Department Medical School, Camden; Cooper of Orthopedic Surgery, Shinshu Health System/University Medical University School of Medicine, Center, Camden, NJ Matsumoto, Japan TAMITARO SOMA, MD • Department SAMANTHA L. SALKELD, MSE • Department of Cardiovascular Surgery, Saiseikai of Orthopaedic Surgery, Tulane Yokohama-shi Nanbu Hospital, University School of Medicine, New Yokohama, Japan Orleans, LA LIPING TANG, PHD• Department PROF. DR. MAX SCHALDACH • Biotronik of Pediatrics, Baylor College GmbH, Erlangen, Germany of Medicine, Houston, TX STEVEN P. SCHMIDT, PHD • Division KUNIO TAKAOKA, MD, PHD • Department of Surgical Research, Summa Health of Orthopedic Surgery, Shinshu University School of Medicine, System, Akron, OH Matsumoto, Japan LOUIS SHUSTER, PHD•Tufts University School of Medicine, Boston, MA HOANG S. TRAN, MD • Department of Surgery, Robert Wood Johnson SAMUEL SIDEMAN, DSC• Department of Medical School, Camden, Camden, NJ Biomedical Engineering; Technion— DEBRA J. TRANTOLO, PHD • Cambridge Israel Institute of Technology, Haifa, Scientific, Inc., Cambridge, MA Israel DR. MARTIN UNVERDORBEN • F. H. SILVER•Department of Pathology, Herz-Kreislauf-zentrum, Rotenburg, UMDNJ-Robert Wood Johnson Germany Medical School, Piscataway, NJ JEROME A. WERKMEISTER, PHD• Division VINCENT SIMONETTI, MD •Department of Molecular Science, CSIRO, of Surgery, Robert Wood Johnson Parkville, Victoria, Australia Medical School, Camden; Cooper DONALD L. WISE, PHD• Department Health System/University Medical of Chemical Engineering, Center, Camden, NJ Northeastern University, Boston, MA BAWA SINGH, PHD • Medical Surface ICHIYA YAMAZAKI, MD, PHD • First Techniques, Mount Laurel, NJ Department of Surgery, Yokohama P. B. SNOWHILL • Department of Pathology, City University School of Medicine, UMDNJ-Robert Wood Johnson Medical Yokohama, Japan School, Piscataway, NJ About the Editors Donald L. Wise, PHD,Senior Editor, is Cabot Joseph D. Gresser, PHD, Coeditor, is the Professor of Chemical Engineering Emeritus at Senior Scientist at Cambridge Scientific, Inc., Northeastern University, Boston, MA. He is the Cambridge MA. He received the PhD degree in Founder and Chairman of Cambridge physical chemistry from Syracuse University, Scientific, Inc., Cambridge, MA. Dr. Wise Syracuse, NY. received the PhD degree from the University Mario V. Cattaneo, PHD, Coeditor, is of Pittsburgh, Pittsburgh, PA. Director, Technology Development, Cam- Debra J. Trantolo, PHD, Coeditor, is bridge Scientific, Inc., Cambridge, MA. He President, Cambridge Scientific, Inc., received his PhD in chemical engineering from Cambridge, MA. Dr. Trantolo received the PhD McGill University, Montreal, Canada. degree in organic chemistry from Clark MICHAEL J. YASZEMSKI, MD, PHD,Coeditor, is University/University of Massachusetts Medical Senior Associate Consultant, Department School, Worcester, MA. of Orthopedics, Mayo Clinic, Rochester, MN. Kai-Uwe Lewandrowski, MD, Coeditor, is He received the MD degree from Georgetown an Orthopedic Research Associate at University School of Medicine, Washington, Massachusetts General Hospital of Harvard DC, and the PhD degree in chemical Medial School. He received the MD degree engineering from the Massachusetts Institute from Humboldt University in Germany. of Technology, Cambridge, MA.