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Biomaterials Science: An introduction to materials in medicine PDF

1600 Pages·2012·117.734 MB·English
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Biomaterials Science An Introduction to Materials in Medicine Third Edition Edited by Buddy D. Ratner, Ph.D. Professor, Bioengineering and Chemical Engineering, Director of University of Washington Engineered Biomaterials (UWEB), University of Washington, Seattle, WA, USA Allan S. Hoffman, Sc.D. 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. University Professor, Schools of Dentistry, Medicine and Engineering, University of Alabama at Birmingham, Birmingham, AL, USA AMSTERDAM • BOSTON • HEIDELBERG • LONDON • NEW YORK OXFORD • PARIS • SAN DIEGO • SAN FRANCISCO • SYDNEY • TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, UK 225 Wyman Street, Waltham, MA 02451, USA First published 1997 Second edition 2004 Third edition 2013 Copyright © 2013 Elsevier Inc. All rights reserved. Exceptions: Chapter I.2.2.D: Acrylics, by Joe Antonucci and Sabine Dickens, is in the public domain; Chapter I.2.2.B Silicones and Chapter II.5.18 Medical Applications of Silicones by Jim Curtis and André Colas is ©2013 Dow Coming Corporation. Published by Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangement with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-374626-9 For information on all Academic Press publications visit our website at store.elsevier.com Printed and bound in Canada 12 13 14 15 10 9 8 7 6 5 4 3 2 1 Contributors. xiil Preface, n i How to Use this Book. xxiii Biomaterials Science: An Evolving, Multidisciplinary Endeavor. xxv Budrly D Rim..-, Alton S Hollm.irt. Ftederick J. Sd>oen, •nd lad: f tomons History of Biomaterials. xli Buddy D. R<>t""' PART ONE Materials Science and Engineering SECTION 1.1 Properties of Materials 1.1.1 Introduction: Properties of Materials: The Palette of the Blomaterlals Engineer, 5 JM:J. £ lomons 1.1.2 The Nature of Matter and Materials. 6 Buddy D R<>ow 1.1.3 Bulk Properties of Materials, 9 v,.,. Clln>tcp/><f I. 1.4 Finite Element Analysis in "B""ioemn,;e,c,.h,a.,n.i,c s, 21 Mm..t So<k~ Antonio D.A""""· Hobson 1.1.5 Surface Properties and Surface Characterization of Biomaterials, 34 Buddy D. R4rnf!f I. 1.6 Role of Water in Biomaterials, 55 Bvddy 0 RiltflH SECTION 1.2 Classes of Materials used in Medicine 1.2.1 Introduction: The Diversity and Versatility of Biomaterials, 63 AJfon S. Hoffman 1.2.2 Polymers: Basic Principles, 64 Din~ F !ream and SIW<t I. ~ A. Polyurethanes, 79 o-.1 £ -~~~ w S~uart L c- 8 . Silicones, 82 - c- Mtd .lin curns C. Fluorinated Biomaterials, 92 rang wand o....t~ w Gra~nge< 0. Acrylics, 103 Joe Antonuca and Sabine Dk'kens vi CONTENTS 1.2.3 Metals: Basic Principles. 111 John B. Brunst•' A. Titanium and Nitlnol (NITi). 120 A/)/oay P•nd>t lw!t> PliJflf!( and M<lt>il Nav..,.o B. Stainless Steels. 124 Pl>•/>p J Af>riorwn 1.2.4 Ceramics. Glasses. and Glass-Ceramics: Basic Principles. 128 1.¥ry L l!encf> ilfld 5ettm M 8<$1 A. Natural and Synthetic Hydroxyapatites. 151 AdtiloLBos.\ty -A B. Alumina. 162 IC<MC Po(»rM>dT.,MA 0.... 1.2.5 Hydrogels, 166 Ptpp•utwl-.s HolftnMI 1.2.6 Degradable and Resorbable Biornaterials, 179 -I.M>gr<. --......... s.JdwAbr- Mtd-/Cohn 1.2.7 Engineered Natural Materials. 19S Glenn 0 A<>""<'> Mtd 5¥111 Au.< 1.2.8 Pyrolytic Carbon For long-Term Medical implants. 209 Rob<tt B.""""-AAoJ 0 Houbold, Mtd-C. Botros 1.2.9 Composites. 223 Cloud!o Mtgh"""' 1.2.10 Non-fouling Surfaces. 241 Buddy D. R.t""" •ne AIIM! S lloflm>n 1.2.11 Applications of "Smart Polymers• as Blomaterlals, 247 A«an S HoHm.tn 1.2.12 Physicochemical Surface Modification of Materials Used in Medicine, 259 Buddy D. RatnOf ane Allan S llollmMJ 1.2.13 Surface Patterning. 276 Ryan T. HIIJ <md AshurW. Chl/kotl 1.2.14 Medical Fibers and Biotextlles. 301 w. M•rrm Kmg """ Songwon Chotlg 1.2.15 Tex1ured and Porous Materials, 321 Hf!Jdl f. Koschw,mez Mid WiJNam M. ReJcfNNt 1.2.16 Electrospinning Fundamentals and Applications, 332 R~rt AkH1$ and Jolm P.lt)o/t 1.2.17 Surface-Immobilized Biomolecules. 339 Ailolfl S Hoflm.tn atwl Jolfr•y A 1/ui>/J<II/ 1.2.18 Biomimetic Materials, 349 o,_ Ekzabeth G..,_ M>ri CMstop/lff l&>fy 1.2.19 Microparticles and Nanoparticles. 360 Sh.>N 5utl. Gong 1i1W1. J<>K• ~Anr«, Chm>IIO £ Schmidt CONTENTS vii PART TWO Biology and Medicine SECTION II. 1 Some Background Concepts 11.1.1 Introduction: Biology and Medicine- Key Concepts in the Use of Biomaterials in Surgery and Medi<al Devices. 393 BuddyO ~- 11.1.2 Adsorbed Proteins on Biomaterlals, 394 Tl>otrwsA-rr 11.1.3 Cells and Surfaces In vitro, 408 s. 4dlmH«~NVJAtl(- 11.1.4 Cell Function and Response to Injury, 427 Rlch¥dN MKMINVIFo-t ~ 11.1.5 Tissues, the Extracellular Matrix, and Cell-Biomaterial Interactions, 452 Foodend/Sdoo«>NVIRI<h¥dN- 11.1.6 Effects of Mechanl<al Fortes on Cells and Tissues (The Uquid-Celllnterface), 474 0an<e1 E Conw.>y. s...,.,.,. G (st.,, NvJ I ;wry V - 11.1.7 Stem Cells: Key Concepts, 487 Rlch¥dL ~NVJToddC M<De•rr SECTION 11.2 Host Reaction to Biomaterials and Their Evaluation 11.2.1 Introduction: Biological Responses to Biomaterials, 499 fff'derlck J Schoen 11.2.2 Inflammation, Wound Healing, and the Foreign·Body Response, 503 James M /Vl<IMoo 11.2.3 Innate and Adaptive Immunity: The Immune Response to Foreign Materials, 512 Rklwd N Motcl••ll 11.2.4 The Complement System, 533 N<horrl 1 Johnson 11.2.5 Systemic Toxicity and Hypersensitivity, 545 Arne Henston and Nils J.xobsoo 11.2.6 Blood Coagulation and Blood-Materials Interactions, 551 Stephen R Hdllson Md ErJk 1 rucker 11.2.7 Tumors Associated with Biomaterials and Implants, 558 fff!dfftd 1 S</o- 11.2.8 Biofilms, Biomaterials, and Oevice·Related Infections, 565 Paul Stoodto!y, h""'t» IIMI·Sto«iity. Boll Coslirrn>f\ Pamck OtMeo. M.lfk ShlrtW fllfn G.lw.Jit ¥od Solndo<p K.tltoju viU CONTENTS SECTION 11.3 Biological Testing of Biomaterials 11.3.1 How Well Will It Work71ntroductlon to Testing Biomaterials, 587 Bu<ldyD R.ttrl<t 11.3.2 The Concept and Assessment of Biocompatibility, 588 Buddy D 11.1-and Fr«<or>ck I Sd>ofn 11.3.3 In Vitro Assessment of Cell and Tissue Compatibility, 593 c-., MocNel F Wolf.Kolly P ¥><fG1f901YM L-.z 11.3.4 In Vivo Assessment of Tissue Compatibility, 609 /ame5 M Andtlnon olnd Ffwdtnck I .!<hom 11.3.S Evaluation of Blood-Materials Interactions, 617 ~0/lo-andlhomlsAHotbt<t 11.3.6 Animal Surgery and Care of Animals, 635 o...du ..I'MfiU 11.3.7 Large Animal Models in Cardiac and Vascular Biomaterials Research and Assessment. 653 - w s.ona. "'-> 1t w-.-, JossgA< V09>t.-r LJ/14 ""'*-L M>d-I' Golfo9os 11.3.8 Mi<roocopy for Blomaterials Sdence, 677 K1pD 11.>/d..,ndBuddyO./Iotn« SECTION 11.4 Degradation of Materials in the Biological Environment 11.4.1 Introduction: The Body fighu Back- Degradation of Materials in the Biological Environment, 695 Bvddy D. flo- 11.4.2 Chemical and Biochemical Degradation of Polymers Intended to be Biostable, 696 Arthur J Coury 11.4.3 The Biodegradation of Biodegradable Polymeric Biomaterials, 716 Ch•ert--Cill Vn #lid KostJ S Anscrh 11.4.4 Degradative Effects of the Biological Environment on Metals and Ceramics, 728 D;,vid f. WitNams ond R11chel L Wfh'lllms 11.4.5 Pathological Calcification of Biomaterlals, 739 Frederldc J Sci!OM Md Robfv't ), Levy SECTION 11.5 Applications of Blomaterials 11.5.1 Introduction: Applications of Blomaterials, 757 FrederiCk J SdiOIN'I M!d .AJck E. Ltmom 11.5.2 Nonthrombogenlc Materials and Strategies: Case Study, 758 Mic/laef v Sefton 11.5.3 Introduction to Cardiovascular Medical Devices, 760 Ftod«~J- A. Substitute Heart Valves, 761 -kJSdloonand_,F-.. Jr B. Endovascular Stenu, Vascular GrafU, and Stent GrafU, 771 -1 Sd>otnM>d-F -._/r CONTENTS ill C. Other Cardiovas<ular Devices. 784 Robert F P~a. Jr Mid Frtdenct J Schoen D. Implantable Cardiac Assist Devices and IABPs. 799 M•rc A Slmoo. ~ S. 8or""'ct WIN""" R W<l9fl« 11.5.4 Artificial Cells. 811 Thoma1 Mmg SWJ CNng 11.5.5 Extracorporeal Artificial Organs. 827 ----/o6/w»-- Alost., Ympbell R.tchl< 11.5.6 Orthopedic Applications. 84t 11.5.7 Dental Implantation. 882 }dck f ,.....,. - ,., f - 11.5.8 Adhesives and Sealants. 889 o.wi~WMIS 11.5.9 Ophthalmologic Appliutions: Introduction. 90S Rage<S""""Mid&khiWI A. Biornaterials: Contact Lenses. 909 )Nn/¥JJb B. Intraocular Lens Implants: A Scientific Perspective. 917 Ar>IS P•lfl C. Corneal Inlays and Onlays. 930 Oynal CuMnMJ D. Ophthalmologic Applications: Glaucoma Drains and Implants, 940 Cl)'stal Cvn.JnMJ E. The Development of a Retinal Prosthesis: A Significant Biomateriafs Challenge. 946 Mark S. HurMyvl\ Adr~ P. Rowlty. John J, Whalen I( Ja/"Ms D. WE'i.l.ind. llld Amllllld R. IIII!IJWY. It 11.5.10 Bloelectrodes. 957 Rilrnakrishna VMu~ Md Rq lc/8~ 11.5.11 Cochlear Prostheses. 967 F-riJncJs A Spchrwn 11.5.12 The Role of Biomaterlals In Stimulating Bioelectrodes. 981 P. Hut!tl>f Peckham D MichNI Ackfffi'Wltt, Jr, Md Christa W. Mosl 11.5.13 Medical Biosensors, 996 Vu Laffeur and P.)ul YB<)ef 11.5.14 Burn Dressings and Skin Substitutes. 1006 DougloH l. H•lm. Bmfyn 0. Oflll~ R•• Og.Jw., ond O.nn~ P OrgoN 11.5.15 Sutures. 1010 M xo<r ray/« and Sl!al•by W 5hll.ll>t 11.5.16 Drug Delivery Systems. 1024 A11111t S. Ho(fm;Jfl, Editor A. Introduction. 1024 AIJ.>n S flollmllfl B. Injected Nan0cw:.1.r,r.i,e. rs. 1021 Nlln S Holfmln. R GOfnbo<l. MWI S...U H Altl. fclrots 11 CONTENTS B.1. Introduction, 1027 Allan S. Hoffman B.2. PEGylation of Drugs and Nanocarriers, 1028 AJ/iJn 5. Hoffman and Suzie H Pun B.3. Targeting, 1028 Patrick S. Stayton. Bi!al Ghosn, and John T. Vii/son B.4. Polymer-Drug Conjugates, 1036 Sulk H, Am and All¥~ S. ~iofftnN~ B.S. Liposomes, 1039 Wclyne R. Gomboa B.6. Polymeric Micelles, 1041 Wayne R. Gomboll ~d Allan S. Hoffman B.7. Dendrimers, 1045 wayne R. Gomborz B.S. Nucleic Acid Delivery, 1047 Suzie H. Pun and ANan S. Hoffrn<N) B.9. Polymeric and Albuminated Drug Nanoparticles, 10S4 Wayn(' R. Gomborz C. Injected Depot DDS, 10SS Wayne R. Gombotz and Allan S. Hoffman D. Implants and Inserts, 1062 (or.tw W Kleiner and Jffl!my C Wff9ht E. Smart DDS, 1071 A/ltN'J $. HO!fm<Nl F. Transdermal DDS, 1073 GalyCIOiiiJ' G. Oral Drug Delivery, 1083 C1iw G. Wi~oo 11.5.17 Diagnostic Applications of Biomaterials, 1087 Gonzalo Domingo, Kenneth R. Hawkins, Roger 8. Peck, and Bernhard H. Wetgl 11.5.18 Medical Applications of Silicones, 1106 Jim CMis Mid Andr< Co liJs SECTION 11.6 Applications of Biomaterials in Functional Tissue Engineering 11.6.1 Introduction: Rebuilding Humans using Biology and Biomaterials, 1119 Fredeflct. J. S<hoen 11.6.2 Overview of Tissue Engineering Concepts and Applications, 1122 Debcln)an Sa1kar. WtVan Zhao, Sebaslian Sdlaefer. Jame5 A Ankrom, Graci! S. L. Teo. Man'a Nunes Petett-'. Lmo Feffe/ra <Jnd Jeffr(!tJ M. K;Jrp 11.6.3 Tissue Engineering Scaffolds, 1138 Milind Singh, F. Kurtis Kasper. and Antonios G. Mikos 11.6.4 Cell Sources for Tissue Engineering: Mesenchymal Stem Cells, 11S9 Arnold 1 c.p~., 11.6.5 Micromechanical Design Criteria for Tissue Engineering Biomaterials, 1165 Kausrabh Ghosh, Charles K. 11lodeli and Donald E. Ingber CONTENTS xi 11.6.6 Bioreactors for Tissue Engineering. 1178 Nin<! Tandon, Elisa Gmetta, Sarindr Bhumirat~na. Arn;mcfine Godier.furnemont, Robert Maidho{. and GouJana Vunjak-Nov<rkovic 11.6.7 Bone Tissue Engineering, 1194 Mtin L &wm, ~ngamesh G. KtJmb~r,. and Caro T La(lrenah 11.6.8 Cartilage and Ugament Tissue Engineering: Biomaterials, Cellular Interactions, and Regenerative Strategies, 1214 Citthen'ne K. Kuo, Wan·Ail.J. and Rocky S. Tuan 11.6.9 Blood Vessel Tissue Engineering, 1237 Stacey C. Schurre and Robert M. Nerem 11.6.1 0 Heart Valve Tissue Engineering, 1246 Frec/efkk J. Schoen and Simon P Hoerst(l)p 11.6.11 Cardiac Muscle Tissue Engineering, 1262 Amandille Godier-FuulernotJl and Gordi'Jfla VunjJk·Nov<JI<OVJ'r: 11.6.12 Tissue-engineered Skin Substitutes.1276 1, N Mafl.'>bridtft 11.6.13 Esophageal and Gastrointestinal Tissue Engineering, 1288 Buddy D. Rdrner 11.6.14 Neuronal Tissue Engineering, 1291 Ravi V. Be/Jamkonda. Isaac P. Gements, and Jenm'fer M. Munson 11.6.15 lmmunoisolation, 1306 Roshni S. Rainbow and •'Alcheel 1. tysagllr 11.6.16 Tissue Engineering with Decellularized Tissues, 1316 Stephen F. Bcdylak. Bryan N. Brown. and Thomas W. Gilbert PART THREE Practical Aspects of Biomaterials SECTION 111.1 Implants, Devices, and Biomaterials: Special Considerations 111.1.1 Introduction: Implants, Devices, and Biomaterials: Special Considerations, 1337 frf!deflck J. Schoon 111.1.2 Sterilization of Implants and Devices, 1339 Byron lamberl and JeHrey Mariill 111.1.3 Correlation, Materials Properties, Statistics and Biomaterials Sdence, 1354 Bvckfy D. R•rne< 111.1.4 Device Failure Mode Analysis, 1361 Fredeodc J. 5(hoen and AJ/aJ1 S. Hoffman 111.1.5 Implant Retrieval and Evaluation, 1368 James M. An~~Wn. Fr«ferkk J, Schoen, SMoky A. Brown. and K.athiJrine Meto'r SECTION 111.2 Voluntary Standards, Regulatory Compliance, and Non-Technical Issues 111.2.1 Introduction: Voluntary Standards, Regulatory Compliance, and Other 1387 Non~technicallssues, Frederid< 1. Sd>Oen IJ()d J•ck E. Lemoos

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