Biomaterials Science, Third Edition: An Introduction to Materials in Medicine

1600 Pages·2012·59.11 MB·English

by  Buddy D. Ratner

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
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Academic Press is an imprint of Elsevier
Academic Press is an imprint of Elsevier
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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.
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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,
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ISBN: 978-0-12-374626-9
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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