Table Of ContentB 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
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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.
