Biomaterials Science – An Introduction to Materials in Medicine

Biomaterials Science – 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
CONTENTS
Editors and Lead Contributors ix
Preface xi
Biomaterials Science: A Multidisciplinary
Endeavor 1
BUDDY D. RATNER, ALLAN S. HOFFMAN, FREDERICK J. SCHOEN,
AND JACK E. LEMONS
A History of Biomaterials 10
BUDDY D. RATNER
PART I
MATERIALS SCIENCE AND
ENGINEERING
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
IVAN VESELY AND EVELYN OWEN CAREW
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
2.2 Polymers 67
STUART L. COOPER, SUSAN A. VISSER,
ROBERT W. HERGENROTHER, AND NINA M. K. LAMBA
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
JOACHIM KOHN, SASCHA ABRAMSON, AND ROBERT LANGER
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
2.11 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
BUDDY D. RATNER AND ALLAN S. HOFFMAN
vvi CONTENTS
2.14 Physicochemical Surface Modification
of Materials Used in Medicine 201
BUDDY D. RATNER AND ALLAN S. 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
PART II
BIOLOGY, BIOCHEMISTRY,
AND MEDICINE
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
THOMAS A. 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,
PAUL STOODLEY, AND MARK PASMORE
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
RICHARD W. BIANCO, JOHN F. GREHAN, BRIAN C. GRUBBS,
JOHN P. MRACHEK, ERIK L. SCHROEDER,
CLARK W. SCHUMACHER, CHARLES A. SVENDSEN,
AND MATT LAHTI
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. LEVYCONTENTS 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,
AND BARTLEY P. GRIFFITH
7.5 Artificial Red Blood Cell Substitutes 507
THOMAS MING SWI CHANG
7.6 Extracorporeal Artificial Organs 514
PAUL S. MALCHESKY
7.7 Orthopedic Applications 527
NADIM JAMES HALLAB, JOSHUA J. JACOBS,
AND J. LAWRENCE KATZ
7.8 Dental Implantation 556
A. NORMAN CRANIN AND JACK E. LEMONS
7.9 Adhesives and Sealants 573
DENNIS C. SMITH
7.10 Ophthalmological Applications 584
MIGUEL F. REFOJO
7.11 Intraocular Lens Implants: A Scientific
Perspective 592
ANIL S. PATEL
7.12 Burn Dressings and Skin Substitutes 603
JEFFREY R. MORGAN, ROBERT L. SHERIDAN,
RONALD G. TOMPKINS, MARTIN L. YARMUSH,
AND JOHN F. BURKE
7.13 Sutures 615
MARK S. ROBY AND JACK KENNEDY
7.14 Drug Delivery Systems 629
JORGE HELLER AND ALLAN S. HOFFMAN
7.15 Bioelectrodes 649
RAMAKRISHNA VENUGOPALAN AND RAY IDEKER
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,
AND JOERG K. TESSMAR
PART III
PRACTICAL ASPECTS OF
BIOMATERIALS
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,
STANLEY A. BROWN, AND KATHARINE MERRITT
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 DUNCANviii CONTENTS
10.4 Ethical Issues in the Development of
New Biomaterials 793
SUBRATA SAHA AND PAMELA SAHA
10.5 Legal Aspects of Biomaterials 797
JAY P. MAYESH AND MARY F. SCRANTON
CHAPTER 11 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
INDEX
A
Absorbable matrix composites, 191
Absorbable synthetic fibers, 90
Absorbable synthetic sutures, 618–621
Absorption, multilayer polyelectrolyte,
211–212
Accommodative IOLs, 598–599
Acids; See Poly(amino acids);
pseudo-poly(amino acids), 119
Act, Biomaterials Access Assurance, 803
Activity, platelet coagulant, 334
Acute inflammation, 298–299
Adaptive immunity
innate and, 304–318
recognition and effector pathways in,
309–311
types of, 309
Adaptor/adhesive molecules, 263
Adhesion
bacterial, 347
platelet, 333
Adhesion proteins, effects of, 238–240
Adhesive biomaterials, composition and
characteristics of, 576–581
Adhesive molecules; See
Adaptor/adhesive molecules
Adhesives
hard-tissue, 579–580
soft-tissue, 576–579
surgical, 590
Adhesives and sealants, 572–583
background concepts, 573–576
characteristics of adhesive
biomaterials, 576–581
composition of adhesive biomaterials,
576–581
historical overview, 572–573
new research directions, 581–582
Adjustable power IOLs, 599
Adsorbed proteins in biomaterials,
importance of, 245
Adsorbed proteins in tissue response to
biomaterials, 237–246
adsorption behavior of proteins at
solid/liquid interfaces, 240–242
conformational and biological
changes, 242–245
effects of adhesion proteins on cellular
interactions, 238–240
importance of adsorbed proteins in
biomaterials, 245
molecular spreading events, 242–245
Adsorption behavior of proteins at
solid/liquid interfaces, 240–242
Adsorption; See also Preadsorption;
sorption
AFM (atomic force microscopy), 51–54,
221
Agar diffusion test, 358
Agents
immobilization of anti-platelet,
465–466
immobilization of fibrinolytic, 466
Aggregation, platelet, 333–334
Allergies, types of, 330–331
Allergy and biomaterials, 330
Allografts
from cadavers, 605–606
of cultured cells and collagen, 606
Alloys
cobalt-based, 144–148
cobalt-chromium, 536–537
new cobalt, 538–539
new tantalum, 537–538
new titanium, 538
new zirconium, 537–538
stainless steel, 536
titanium, 537
titanium-based, 148–151
Alloys, new, 537–539
new cobalt alloys, 538–539
new stainless steels, 539
new titanium alloys, 538
new zirconium and tantalum alloys,
537–538
surfaces and coatings, 539
Amino acids; See Poly(amino acids);
pseudo-poly(amino acids)
Amorphous matrix, 265
Analyses, finite element, 32–40
continuum equations, 35–36
examples from biomechanics, 37–40
finite element equations, 36–37
overview of finite element method,
33–35
surface analysis techniques, 42–56
Analyses, gene expression, 808
Animal experimentation, 794
Animal models and species
consideration, 381–390
canine, 381–386
sheep, 388–390
swine, 386–388
Animal models in cardiac research
testing, large, 379–396
Animal models in research testing, large
animal models and species
consideration, 381–390
responsible use of animals, 380–381
testing hierarchies, 390–392
Animal models in vascular research
testing, large, 379–396
Animal models, selection of for in vivo
tests, 364–365
Animal tumors, implants with human
and, 339–341
Animals, responsible use of, 380–381
Anti-platelet agents, immobilization of,
465–466
Antibody-mediated disease, pathogenesis
of, 313–314
antibody bound to cell surfaces or
fixed tissue antigens, 313–314
831832 INDEX
Antibody-mediated disease, pathogenesis
of (Continued)
IC (immune complex)-mediated injury,
314
IgE-mediated (immediate
hypersensitivity), 313
Apheresis, 516–524
centrifugal plasma separation,
519–520
cytapheresis, 523–524
defined, 518
membrane plasma filtration, 522–523
membrane plasma separation,
520–522
miscellaneous physicochemical
methods, 523
plasma exchange, 518–519
plasma treatment, 522
sorption plasma fractionation, 523
Apoptosis, 258–259
Apparatus, Golgi, 253–254
Apparel, drapes and protective, 97–98
Applications
bioelectrodes, 654–655
EO sterilization, 757–758
ophthalmological, 583–591
orthopedic, 526–555
of scaffolds, 737–740
in vivo, 97–99
Approaches
variational, 36
weighted residual, 36
Arms, linker, 692–694
Arrays, neuronal electrode, 808
Arrhythmias, cardiac, 483–485
Artery stents, coronary, 476–479
Arthroplasty
mold, 529–531
total hip replacement, 531–532
Arthroplasty, history of total hip,
529–532
femoral head prostheses, 531
long-stem prostheses, 531
mold arthroplasty, 529–531
short-stem prostheses, 531
total hip replacement arthroplasty,
531–532
Artifacts, 280
Artificial devices; See Bioartificial devices
Artificial endothelium, 588
Artificial epithelium, epikeratophakia
and, 587–588
Artificial heart, total implantable, 489
Artificial heart valves, 38–40, 798–799
Artificial organs, 709–748
extracorporeal, 514–526
immunoisolation, 728–734
overview of tissue engineering,
712–728
synthetic bioresorbable polymer
scaffolds, 735–747
Artificial prosthesis, 712
Artificial red blood cell substitutes,
507–514
hemoglobin, 507
modified hemoglobin, 507–511
perfluorochemicals, 511–512
Assay methods, 357–359
agar diffusion test, 358
direct contact test, 357–358
elution test, 358
interpretation of results, 358–359
Assays, new solid-phase materials for
ligand binding, 686–692
miscellaneous biosensor strategies,
691–692
molecularly imprinted surfaces,
690–691
particles, 686–689
self-assembled monolayers, 690
surface-enhanced spectroscopies, 691
Assessment, key considerations for BMI,
370–373
blood-factors affecting its properties,
370–371
blood interaction times, 373
how flow affects blood interactions,
371–372
properties of biomaterials and devices,
373
surfaces, 373
Assist
cardiac, 486–490
kidney, 514–518
lung substitutes and, 524
Assist devices
implantable cardiac, 494–503
ventricular, 487–489
Assurance Act, Biomaterials Access, 796
ASTM F67, 148
ASTM F75, 146
ASTM F90, 147
ASTM F136, 149
ASTM F562, 147–148
ASTM F799, 147
Atherosclerotic vascular disease, 476–483
Atomic structure, 25
Atopy, 331
Attachment, tissue, 154–155
Attack complex, membrane, 322
Auditory system, overview of, 658–659
Authorship, 795
B
Background concepts, 237–288
adsorbed proteins in tissue response to
biomaterials, 237–246
cells and cell injury, 246–260
mechanical forces on cells, 282–287
tissues and cell-biomaterial
interactions, 260–281
Bacterial adhesion to surfaces, 347
Behavior, elastic, 27
Bioactive glasses and glass-ceramics,
160–163
Bioactive molecules, delivery of, 732
Bioartificial devices, 525
Bioceramics
characteristics and processing of,
155–157
types of, 154–155
Biocompatibility, 809–810
and medical device performance,
765–766
of pyrolytic carbon, 177–179
standards, 786–787
Biocompatibility testing, ISO standard
for, 791–792
Biodegradable polymers, 79
Biodegradation, hydrolytic, 412–416
host-induced hydrolytic processes,
413–414
hydrolysis-preclinical and clinical
experience, 414–416
structures of hydrolyzable polymers,
412–413
Biodegradation, oxidative, 416–427
device- or environment-mediated
oxidation, 421–425
direct oxidation by host, 418–421
oxidation reaction mechanisms and
polymer structures, 416–418
oxidative degradation induced by
external environment, 425–427
Bioelectrodes, 649–656
applications, 654–655
electrode-electrolyte interface,
650–651
electrode materials, 653
equivalent circuit models, 651–652
factors influencing material selection,
652–653
Bioerodible materials, bioresorbable and,
115–127
applications of synthetic degradable
polymers as, 121–125
currently available degradable
polymers, 116–121
definitions and process of erosion
and/or degradation, 116
Bioerosion
factors influencing rate of, 124–125
process of, 123
Biofilm control, novel engineering
approaches to, 349
Biofilm formation on surfaces, 347–349INDEX 833
Biofilm microbiology, 346–347
bacterial adhesion to surfaces, 347
biofilm formation on surfaces,
347–348
natural control of biofilm formation
on surfaces, 348–349
novel engineering approaches to
biofilm control, 349
Biofilm-resistant biomaterials, 349–352
control of microbial colonization of
biomaterials, 351
delivery of biofilm control agents,
351–352
testing for antibacterial and antibiofilm
properties, 349–351
Biofilms, biomaterials and device-related
infections, 345–353
Biological effects of surface
microtexture, 222–224
Biological environment
corrosion and corrosion control in,
434–437
degradation of materials in, 411–453
influence of, 434
Biological fluids, properties of, 813–817
Biological properties assessed by in vivo
tests, specific, 366–368
Biological response to materials, water
and, 63–64
Biological stimuli, smart gels that
respond to, 112
Biological testing of biomaterials,
359–409
evaluation of BMIs (blood-materials
interactions), 371–383
large animal models in cardiac
research testing, 383–396
large animal models in vascular
research testing, 383–396
microscopy for biomaterials science,
396–409
in vitro assessment of tissue
compatibility, 360–364
Biology; See Microbiology; pathobiology
Biomaterial corrosion, orthopedic,
541–543
Biomaterial, silk as, 807–808
Biomaterial wear, orthopedic, 540–541
Biomaterials
adsorbed proteins in tissue response to,
235–244
allergy and, 334
biological testing of, 359–409
composition and characteristics of
adhesive, 576–581
and device-related infections, 349–357
and glucose sensing meet photonics,
805–806
importance of adsorbed proteins in,
245
inflammatory reaction to, 293–294
lack of pure and safe natural, 806
orthopedic, 528, 539–553
role of water in, 59–64
synthetic degradable polymers and,
121–125
tissue-derived, 317–318
tissue engineering using scaffold, 709
Biomaterials Access Assurance Act, 797
Biomaterials, biofilm-resistant, 349–352
control of microbial colonization of
biomaterials, 351
delivery of biofilm control agents,
351–352
testing for antibacterial and antibiofilm
properties, 349–351
Biomaterials components, kinetics and
nature of, 328–329
Biomaterials design, orthopedic, 524
Biomaterials, diagnostics and, 685–697
ligand immobilization on solid phases,
692–695
solid phase immunoreagents, 695–696
solid-phase materials for ligand
binding assays, 686–692
Biomaterials, ethical issues in
development
of new, 793–795
animal experimentation, 794
authorship, 795
clinical trials, 793–794
industrial support for research,
794–797
patents, 796–797
regulation, 795–796
Biomaterials, history of, 10–19
biomaterials before World War II,
10–12
contemporary era, 18–19
designed biomaterials, 17–18
modern biology and modern materials,
18–19
post World War II, 12–17
surgeon/physician hero, 12–17
Biomaterials, host reactions to,
293–350
biofilms, biomaterials and
device-related infections, 345–353
blood coagulation and blood-materials
interactions, 332–336
complement system, 318–328
immune response to foreign materials,
304–318
infection, 295–296
inflammation, wound healing and
foreign-body response, 296–304
inflammatory reaction to biomaterials,
293–294
innate and adaptive immunity,
304–318
systemic and remote effects, 294–295
systemic toxicity and hypersensitivity,
328–332
thromboembolic complications, 295
tumorigenesis, 295
tumorigenesis and biomaterials,
338–345
Biomaterials, legal aspects of, 797–804
artificial heart valves, 799–800
Biomaterials Access Assurance Act,
803
defensive manufacturing and
marketing, 804
intrauterine devices, 798–799
liability of design engineers, 803
pacemakers, 800
pedicle screws, 800–801
preemption, 802
science in courtrooms, 802–803
silicone breast implants, 801–802
Biomaterials, polymeric, 78–79
biodegradable polymers, 79
copolymers, 79
Biomaterials science, correlation,
surfaces and, 765–771
aspects of bioreaction to biomaterials,
767
biocompatibility and medical device
performance, 765–766
case for correlation, 767–769
correlation, 766–767
data, information, and statistics, 766
issues complicating simple
correlation, 769
multivariate correlation, 769–770
Biomaterials science, microscopy for,
396–409
configurations, 396–397
digital imaging, 404–406
fluorescence microscopy, 398–404
light microscopy, 397–398
magnification, resolution, and
contrast, 396
Biomaterials science – multidisciplinary
endeavor, 1–9
biomaterials and biomaterials
science, 1–2
biomaterials literature, 9
biomaterials societies, 9
characteristics of biomaterials
science, 4–6
examples of biomaterials applications,
2–4
subjects integral to biomaterials
science, 6–9834 INDEX
Biomaterials science, perspectives and
possibilities in, 805–829
biocompatibility, 809–810
biomaterials and glucose sensing meet
photonics, 805–806
circulating endothelial progenitor cells,
809
dental materials, 809
DNA technologies, 807
ethics, 810
gene expression analysis, 808
lack of pure and safe natural
biomaterials, 806
miscellaneous stem cells, 809
molecular imaging, 809
neuronal electrode arrays, 808
novel elastic and smart biopolymers,
808
self-assembled materials, 806
silk as biomaterial, 807–814
Biomaterials, tumorigenesis and,
338–345
implants with human and animal
tumors, 339–341
pathobiology of foreign body
tumorigenesis, 341–344
Biomechanics, examples from, 37–40
Biomedical sensors and biosensors, 670
Biomedical specialists, challenges to, 760
Biomolecules, surface-immobilized,
225–233
immobilization methods, 227–230
Biopolymers, novel elastic and smart,
813
Bioprosthetic heart valve calcification,
443–444
Bioresorbable and bioerodible materials,
115–127
applications of synthetic degradable
polymers, 121–125
currently available degradable
polymers, 116–121
definitions and process of erosion
and/or degradation, 116
Bioresorbable polymer scaffolds,
synthetic, 735–749
applications of scaffolds, 737–740
cell seeding and culture in 3D
scaffolds, 745–746
characterization of processed scaffolds,
745
scaffold design, 735–736
scaffold materials, 736–737
scaffold processing techniques,740–744
Biosensor strategies, miscellaneous,
691–692
Biosensors, 679–683
background, 680
sensing modalities, 680–683
Biosensors, biomedical sensors and, 670
biocompatibility, 673–674
biosensors, 679–683
classes of sensors, 674–679
consuming versus nonconsuming
sensors, 671–672
duration of use, 672–673
interaction of sensor with its
environment, 671
micrototal analytical systems, 682
physical versus chemical sensors, 670
sensors in modern medicine, 670
site of measurement, 672
Biosynthetic machinery, 253–254
Biotextiles, medical fibers and, 86–100
applications, 95–99
drapes and protective apparel, 95–99
medical fibers, 87–94
processing and finishing, 94
testing and evaluation, 94–95
topical and percutaneous applications,
97
in vivo applications, 97–99
Bladders, polymeric, 440–441
Bleeding, 505–506
Blood; See also Plasma/blood
Blood cell substitutes, artificial red,
507–514
hemoglobin, 507
modified hemoglobin, 507–511
perfluorochemicals, 511–512
Blood coagulation and blood-materials
interactions, 332–338
biofilm microbiology, 346–349
coagulation, 334
control mechanisms, 336–338
mechanisms of coagulation, 334–336
platelets, 332–334
Blood compatibility
defined, 367
measuring, 367–368
Blood contacting materials, 495–498
Blood interactions, how flow affects,
371–372
Blood-materials interactions, blood
coagulation and, 332–338
coagulation, 334
control mechanisms, 336–338
mechanisms of coagulation, 334–336
platelets, 332–334
Blood pumps
for chronic circulatory support,
502–505
polymeric bladders in, 440–441
Blood vessels, 720
BMI assessment, key considerations for,
370–373
blood-factors affecting its properties,
370–371
blood interaction times with materials
and devices, 373
how flow affects blood interactions,
371–372
properties of biomaterials and devices,
373
surfaces, 373
BMI evaluation, contemporary concepts
in, 377–378
BMIs (blood-materials interactions), 367
BMIs (blood-materials interactions),
evaluation of, 367–379
blood compatibility, 367
contemporary concepts in BMI
evaluation, 377–378
evaluation of BMIs, 374–377
key considerations for BMI
assessment, 370–373
measuring blood compatibility,
367–368
thrombogenicity, 368–370
in vitro tests of BMIs, 374–375
in vivo evaluation of devices, 376–377
in vivo tests of BMIs, 375–376
Bonding
covalent, 23–24
fiber, 741
ionic, 23
metallic, 24–25
weak, 25
Bone, 719
Braids, 95
Breast implants, 441–442
Breast implants, silicone, 801–802
Brittle fracture, 29
Burn dressings and skin substitutes,
602–614
advances in burn treatment, 602
permanent skin substitutes, 609–613
temporary skin substitutes, 605–609
wound coverage and healing, 602–605
wound coverage and skin substitutes,
604–605
C
Cadavers, allografts from, 605–606
Calcification, pathological, 439–451
assessment of biomaterials
calcification, 440–442
pathologic biomaterials and medical
device calcification, 440–442
pathophysiology, 444–448
prevention of calcification, 448–451
Calcified tissues, structure and properties
of, 528–529
Calcium phosphate
ceramics, 162–165
coatings, 165–166
Calcium phosphates, resorbable, 166
Canine, 381–386INDEX 835
Carbon
elemental, 169
pyrolytic, 38, 168–180
Carbon, biocompatibility of pyrolytic,
177–179
Carbon components, steps in fabrication
of pyrolytic, 173–177
Carbon fibers, 182
Carcinogenesis, 551–552
Cardiac arrhythmias, 483–485
Cardiac assist and replacement devices,
486–490
cardiopulmonary bypass, 486–487
complications of cardiac assist devices,
489–490
IABPs (intraaortic balloon pumps),
487
total implantable artificial heart, 489
ventricular assist devices, 487–489
Cardiac assist devices, complications of,
489–490
Cardiac assist devices, implantable,
494–507
blood contacting materials, 495–498
clinical need and applications,
494–495
complications and VAD
biocompatibility issues, 498–502
rotary blood pumps for chronic
circulatory support, 502–505
VADs (ventricular assist devices),
495–498
Cardiac pacemakers, 483–485
Cardiovascular devices, miscellaneous,
490–491
Cardiovascular implants, 777–778
Cardiovascular medical devices,
470–494
atherosclerotic vascular disease,
476–483
cardiac assist and replacement devices,
486–490
miscellaneous cardiovascular devices,
490–491
pacemakers and ICDs, 483–485
stents and grafts, 476–483
substitute heart valves, 472–476
Cartilage, 718–719
Cataracts, introduction to, 587–588
Cell-biomaterial interactions, 260–281
Cell housekeeping, normal, 246–248
Cell injection method, 713
Cell injury and regeneration, 255–256
Cell-matrix interactions, 265
Cell-mediated disease, pathogenesis of,
314–317
Cell regenerative capacity, 273–274
Cell responses to mechanical forces,
vascular, 282–285
Cell seeding and culture in 3D scaffolds,
745–746
miscellaneous culture conditions, 746
profusion culture, 746
rotary vessel culture, 746
spinner flask culture, 745–746
static culture, 745
Cell specialization and differentiation,
255
Cell/tissue-biomaterials interactions,
272–275
Cell transplantation, 737–738
Cells, 732
allografts of cultured, 606
circulating endothelial
progenitor, 809
combined with synthetic membranes,
608
endothelial, 462
identification, genotyping, and
functional assessment of, 280
miscellaneous stem, 809
red, 338
white, 338
Cells and cell injury, 246–260
apoptosis, 258–259
biosynthetic machinery, 253–254
causes of cell injury, 256–257
cell injury and regeneration, 255–256
cell specialization and differentiation,
255
cellular integrity and movement,
251–252
cytoskeleton, 251–252
energy generation, 254–255
Golgi apparatus, 253–254
lysosomes and proteasomes, 254
mitochondria, 254–255
necrosis, 258
normal cell housekeeping, 246–248
nucleus-central control, 252–253
pathogenesis of cell injury, 257
plasma membrane, 248–251
responses to cell injury, 257–258
rough and smooth ER (endoplasmic
reticulum), 253–254
waste disposal, 254
Cells and tissues, techniques for
analyses of, 276
artifacts, 280
electron microscopy, 279–280
identification and functional
assessment of cells, 280
light microscopy, 277–279
synthetic products in cells or tissue
sections, 280
three-dimensional interpretation, 280
Cells, mechanical forces on, 282–287
skeletal cell responses to mechanical
forces, 285–287
vascular cell responses to mechanical
forces, 282–285
Cells or tissue sections, synthetic
products in, 280
Cellular integrity and movement,
251–252
Cellular interactions, adhesion proteins
and, 238–240
Centrifugal plasma separation, 519–520
Ceramic degradation, 437–438
Ceramics, degradation effects on, 430
ceramic degradation, 437–438
corrosion and corrosion control,
434–437
influence of biological environment,
434
Ceramics, glasses and glass-ceramics,
153–168
bioactive glasses and glass-ceramics,
159–162
calcium phosphate ceramics, 162–165
calcium phosphate coatings, 165–166
characteristics and processing of
bioceramics, 155–157
clinical applications of HA
(hydroxyapatite), 166
nearly inert crystalline ceramics,
157–158
porous ceramics, 158–159
resorbable calcium phosphates, 166
types of bioceramics, 154–155
Ceramics; See also Bioceramics;
glass-ceramics, 25, 183, 534–535
calcium phosphate, 162–165
nearly inert crystalline, 157–158
porous, 158–159
Cervical spine, finite element model for
lower, 37–38
Chemical compositions of metals used
for implants, 822–823
Chemical degradation, mechanisms of,
123–124
Chemical sensors, 676–679
Chemical sensors, physical versus,
670
Chemically controlled delivery systems,
633–638
Chromium alloys; See Cobalt-chromium
alloys
Chronic inflammation, 299–304
Classical pathway, 319–320
Clinical applications of HA
(hydroxyapatite), 166
Clinical correlates, 325–327
Clinical trials, 793–794
of unapproved devices, 790–791836 INDEX
Closed-mold processes, 186
Closed-system method, 713
Coagulant activity, platelet, 334
Coagulation, 334
Coagulation, blood, 332–338
biofilm microbiology, 346–349
coagulation, 334
control mechanisms, 336–338
mechanisms of coagulation, 334–336
platelets, 332–334
Coagulation, mechanisms of, 334–336
Coatings
calcium phosphate, 165–166
conversion, 212
enteric, 640
new alloys and surface, 537–539
parylene, 212–213
Cobalt alloys, new, 538–539
Cobalt-based alloys, 145–149
Cobalt-chromium alloys, 536–537
Cochlear prostheses, 658–669
directions for future, 667
materials and electrode arrays,
661–666
overview of auditory system, 658–659
Collagen
allografts of cultured cells and, 606
biological consequences of, 132–134
chemical modification of, 132–134
graft copolymers of, 136
native structure of, 130–132
structure of native, 128–130
Collagen and elastin, 262–265
calcification of, 448
Colorants, 622–623
Compatibility; See also Biocompatibility
blood, 367
measuring blood, 367–368
in vitro assessment of tissue, 356–360
in vivo assessment of tissue, 360–367
Complement receptors, 324–325
Complement system, 318–328, 337–338
AP (alternative pathway), 320–322
classical pathway, 319–320
clinical correlates, 325–327
complement receptors, 324–325
control mechanisms, 322–324
future directions, 327
lectin pathway, 320
membrane attack complex, 322
Complexation hydrogels, 105
Complications, thromboembolic, 295
Components
kinetics and nature of biomaterials,
328–329
steps in fabrication of pyrolytic
carbon, 173–177
Composites, 180–196
absorbable matrix, 190
continuous fiber, 186–187
fracture fixation, 190–193
matrix systems, 183–184
mechanical and physical properties of,
186–190
particulate, 189–190
reinforcing systems, 182–183
short-fiber, 189
total joint replacement, 193
Composites, fabrication of, 184–186
fabrication of fiber-reinforced
composites, 184–186
fabrication of particle-reinforced
composites, 184
Composition, surface, 56–57
Compression molding, 742
Concepts, background, 237–288
adsorbed proteins in tissue response to
biomaterials, 237–246
cells and cell injury, 246–260
mechanical forces on cells, 282–287
tissues and cell-biomaterial
interactions, 260–281
Configurations, testing of
materials/design, 762–763
Consensus standards, voluntary,
783–788
biocompatibility standards, 786–787
standards, 783–784
users of standards, 784–785
writers of standards, 785–786
Constants, elastic, 28
Consuming versus nonconsuming
sensors, 671–672
Consumption, platelet, 56–57, 334
Contact-angle correlations, 57
Contact angle methods, 44–45
Contact lenses, 583–587
flexible perfluoropolyether lenses, 586
general properties, 583–584
rigid, 586–587
soft, 442
soft hydrogel, 584–586
Contact profilometry, 220
Continuous fiber composites, 186–187
Continuum equations, 35–36
Control, novel engineering approaches to
biofilm, 349
Conversion coatings, 212
Copolymers, 74, 79
Cornea, 715
Corneal implants; See also Intracorneal
implants, 587–589
Corneas, plastic, 589
Coronary artery stents, 476–479
Correlates, clinical, 325–327
Correlation, surfaces and biomaterials
science, 765–771
issues complicating simple correlation,
769
multivariate correlation, 769–770
Correlations
contact-angle, 57
issues complicating simple, 769
multivariate, 769–770
Corrosion
crevice, 436
fretting, 436
galvanic, 436–437
intergranular, 436
metallic, 432–434
orthopedic biomaterial, 542–544
pitting, 435
Corrosion cracking, stress, 436
Courtrooms, science in, 802–803
Covalent bonding, 23–24
Cracking, stress corrosion, 436
Creep and viscous flow, 30–31
Crevice corrosion, 436
Crystalline ceramics, nearly inert,
158–159
Crystallinity, 73
Culture
profusion, 746
rotary vessel, 746
spinner flask, 745–746
static, 745
Culture conditions, miscellaneous,
746
Culture in 3D scaffolds, cell seeding and
culture, 745–746
Cytapheresis, 523–524
Cytoskeleton, 251–252
D
DDS (drug delivery systems), 628–648
chemically controlled delivery systems,
633–638
diffusion-controlled delivery systems,
628–631
enteric coatings, 640
nucleic acid delivery systems, 640
particulate systems, 642–645
polymer therapeutic delivery systems,
642
regulated delivery systems, 641–642
in situ gelling delivery systems, 638
in situ precipitating delivery systems,
638
water penetration-controlled delivery
systems, 631–633
Defense mechanisms, adverse effects of,
329–330INDEX 837
Defensive manufacturing and marketing,
804
Deformation, plastic, 29–30
Degradable medical implants,
classification of, 121–123
Degradable polymers and biomaterials,
synthetic, 121–125
Degradable polymers, currently
available, 116–121
poly(amino acids), 119–121
pseudo-poly(amino acids), 119–121
Degradation
ceramic, 437–438
definitions and process of erosion
and/or, 116
mechanisms of chemical, 123–124
Degradation studied by SIMS,
poly(glycolic acid), 57
Degradative effects on metals and
ceramics, 430–439
ceramic degradation, 437–438
corrosion and corrosion control,
434–437
influence of biological environment,
438
Delivery systems
chemically controlled, 633–638
diffusion-controlled, 628–631
nucleic acid, 640
polymer therapeutic, 642
regulated, 641–642
in situ gelling precipitating, 638
in situ precipitating, 638
water penetration-controlled, 631–633
Dental implantation, 555–572
clinical environment, 567–569
currently used implant modalities,
559–566
general aspects of packaging and
preparation, 570
history, 555–559
tissue interfaces, 566–567
trends in research and development,
569–570
Dental implants, orthopedic and,
779–780
Dental materials, 809
Dentistry, application of materials in
medicine and, 455–707
adhesives and sealants, 572–583
dental implantation, 555–572
extracorporeal artificial organs,
514–526
strategies to lower thrombogenicity of
metals, 466
use of endothelial cells and RGD
peptides, 466
Deposition, LB (Langmuir-Blodgett),
208–209
Design
orthopedic biomaterials, 528
scaffold, 735–736
Design configurations, testing of
materials, 762–763
Design engineers, liability of, 803
Development of new biomaterials,
ethical issues in, 793–797
animal experimentation, 794
authorship, 795
clinical trials, 793–794
industrial support for research,
794–797
patents, 796–797
regulation, 795–796
Development, role of implant retrieval in
device, 776–777
Device development, role of implant
retrieval in, 776–777
Device failure, implant and, 760–765
biological testing of implants, 763
clinical handling and surgical
procedure, 764
design, 762
packaging, shipping, and storage, 764
patient/user, 764
raw materials, fabrication, and
sterilization, 763–764
testing of materials/design
configurations, 762–763
Devices
bioartificial, 525
changes to regulated medical, 792–793
clinical trials of unapproved, 790–791
immunologic toxicity of medical, 327
intrauterine, 798–799
miscellaneous cardiovascular, 490–491
sterilization of implants and, 754–760
ventricular assist, 487–489
in vivo evaluation of, 372–373
Devices, implantable cardiac assist,
494–507
blood contacting materials, 495–498
clinical need and applications,
494–495
complications and VAD
biocompatibility issues, 498–502
VADs (ventricular assist devices),
495–498
Diagnostics and biomaterials, 685–697
ligand immobilization on solid phases,
692–695
solid phase immunoreagents, 695–696
solid-phase materials for ligand
binding assays, 686–692
Dialysis, 514–518
Differential formulation, 35
Digital imaging, 404–406
Direct contact test, 357–358
Diseased tissues or organs, metabolic
products of, 712
Diseases
atherosclerotic vascular, 476–483
pathogenesis of cell-mediated,
314–317
valvular heart, 472–476
Diseases, pathogenesis of
antibody-mediated, 313–314
antibody bound to cell surfaces or
fixed tissue antigens, 313–314
IC (immune complex)-mediated injury,
314
IgE-mediated (immediate
hypersensitivity), 313
Dislocation, total hip, 37
Disposal, waste, 252
Distribution, mw (molecular weight),
509
DNA technologies, 807
Drapes and protective apparel, 96–97
Dressings
burn, 602–614
hydrocolloid, 608
Diffusion-controlled delivery systems,
628–631
E
ECM (extracellular matrix), 262–265
adaptor/adhesive molecules, 265
amorphous matrix, 265
collagens and elastin, 262–265
GAGs (glycosaminoglycans), 265
proteoglycans and hyaluronan, 265
Ectodermal derived tissue, 714–716
Elastic behavior, 27
Elastic constants, 28
Elasticity, 29
Elastin, 136
calcification of collagen and, 448
collagens and, 262–265
Elastomers, silicone, 82–84
cross-linking by addition, 83
cross-linking by condensation, 82–83
cross-linking with radicals, 82
elastomer filler, 83–84
Electrodes; See also Bioelectrodes
Electrode arrays, neuronal, 808
Electrode-electrolyte interface, 650–651
electrical double layer, 650–651
faradaic and nonfaradaic processes,
650
polarizable and nonpolarizable
electrodes, 650
Electron beam sterilization, 759
Electron microscopy, 279–280, 406–408
elemental analysis in SEM, 408
focused ion beam instruments, 408838 INDEX
Electron microscopy (Continued)
low-voltage imaging, 408
SEM (scanning electron microscopy),
404–408
variable pressure and ESEM, 408
Electron spectroscopy for chemical
analysis (ESCA), 45–46
Electrospinning, 88–89
Element analysis, finite, 32–40
continuum equations, 35–36
examples from biomechanics, 37–40
finite element equations, 36–37
overview of finite element method,
33–35
surface analysis techniques, 42–56
Element equations, finite, 36–37
Elemental carbon, 169
Elution test, 358
Embolism; See Thromboembolism
Encapsulation, concept of, 728
Encapsulation, fibrosis/fibrous, 302–304
Endoderm, 716–718
Endothelial cells and RGD peptides, 466
Endothelial progenitor cells, circulating,
808
Endothelium, artificial, 587
Energy generation, 252–253
Engineering, applications of tissue,
714–722
ectodermal derived tissue, 714–716
endoderm, 716–718
mesoderm, 718–722
Engineering, overview of tissue, 712–728
applications of tissue engineering,
714–722
future perspectives, 722
lost tissue or organ function, 712–728
replacing lost tissue or organ function,
713–714
Engineering, superstructure, 742
Engineers, liability of design, 803
Enteric coatings, 640
Environment
corrosion control in biological,
434–437
degradation of materials in biological,
411–453
influence of biological, 434
nature of plasma, 206
Environmental SEM (ESEM), 408
EO sterilization, 757–758
advantages and disadvantages, 758
applications, 758
EO residuals issues, 758
process and mechanism of action, 757
Epikeratophakia and artificial
epithelium, 587–588
Epithelium, epikeratophakia and
artificial, 587–588
Equations
continuum, 35–36
finite element, 36–37
ER (endoplasmic reticulum), rough and
smooth, 253–254
Erosion and/or degradation, definitions
and process of, 116
Erosion; See also Bioerosion
ESCA (electron spectroscopy for
chemical analysis), 45–46
ESEM (Environmental SEM), 408
Etching, reactive plasma and ion, 219
Ethical issues in development of new
biomaterials, 793–797
animal experimentation, 794
authorship, 795
clinical trials, 793–794
industrial support for research,
794–797
patents, 796–797
regulation, 795–796
Ethics, 810
Evaluation, contemporary concepts in
BMI, 377–378
Events, molecular spreading, 242–245
Examples from biomechanics, 37–40
Experimentation, animal, 794
Extracellular matrix
and cell-biomaterial interactions,
260–281
remodeling, 272
Extracorporeal artificial organs,
514–526
apheresis, 518–524
bioartificial devices, 525
development of extracorporeal
artificial organs, 525
kidney assist, 514–518
lung substitutes and assist, 524
Extrusion, 742–743
Eye, introduction to optics of, 591–592
F
Fabrication, effect on strength, 32
Fabrics, woven, 92–94
Failure, heart, 486–490
Failure, implant and device, 760–765
biological testing of implants, 763
clinical handling and surgical
procedure, 764
design, 762
packaging, shipping, and storage, 764
patient/user, 764
raw materials, fabrication, and
sterilization, 763–764
testing of materials/design
configurations, 762–763
Fatigue, 31
Femoral head prostheses, 531
Fiber bonding, 741
Fiber selection, polymer and, 89–90
Fibers
absorbable synthetic, 90
carbon, 182
hybrid bicomponent, 91–92
modified natural, 90–91
polymer, 182–183
Fibers, medical, 86–100, 87–94
absorbable synthetic fibers, 90
hybrid bicomponent fibers, 91–92
modified natural fibers, 90–91
synthetic fibers, 87–90
Fibers, synthetic, 87–90
electrospinning, 88–89
melt spinning, 87–88
polymer and fiber selection, 89–90
wet spinning, 88
Fibrinolysis, 333
Fibrinolytic agents, immobilization of,
466
Fibrosis/fibrous encapsulation, 202–304
Filament-winding process, 186
Filtration, membrane plasma, 522–523
Finite element analysis, 32–40
Finite element equations, 36–37
Finite element method, overview of,
33–35
Fixation, fracture, 190–193
Flask culture, spinner, 745–746
Flow, creep and viscous, 30–31
Fluids, properties of biological, 813–817
Fluorescence microscopy, 398–404
Foreign-body reaction, 301–302
Foreign-body response, 296–304
Foreign body tumorigenesis,
pathobiology of, 341–344
Foreign materials, immune response to,
304–318
Formation; See also Deformation
Formation on surfaces, natural control
of biofilm, 348–349
Formulations
differential, 35
variational, 35–36
Fractionation, sorption plasma, 519
Fracture, brittle, 29
Fracture fixation, 190–193
Freeze-drying, 742
Fretting corrosion, 432
Functions
IOLs with variations of optical,
597–599
properties of interpolating, 36–37
replacing lost tissue or organ, 713–714
Functions, therapeutic approaches for
lost tissue or organ, 712
artificial prosthesis, 712INDEX 839
metabolic products of diseased tissues
or organs, 712
surgical reconstruction, 712
transplantation, 712
G
GAGs (glycosaminoglycans), 134–136,
263
Galvanic corrosion, 436–437
Gas foaming (GF), 743
Gas processes, miscellaneous, 205–206
Gene expression analysis, 808
Generation, energy, 254–255
Genotoxicity, 362–363
GF (gas foaming), 744
Glass-ceramics, bioactive glasses and,
159–162
Glass-ceramics, ceramics, glasses and,
153–168
bioactive glasses and glass-ceramics,
159–162
calcium phosphate ceramics, 162–165
calcium phosphate coatings, 165–166
characteristics and processing of
bioceramics, 155–157
clinical applications of HA
(hydroxyapatite), 166
nearly inert crystalline ceramics,
157–158
porous ceramics, 158–159
resorbable calcium phosphates, 166
types of bioceramics, 154–155
Glasses, 183
bioactive, 159–162
inorganic, 25–26
Glasses and glass-ceramics, ceramics,
153–168
bioactive glasses and glass-ceramics,
159–162
calcium phosphate ceramics, 162–165
calcium phosphate coatings, 165–166
characteristics and processing of
bioceramics, 155–157
clinical applications of HA
(hydroxyapatite), 166
nearly inert crystalline ceramics,
157–158
porous ceramics, 158–159
resorbable calcium phosphates, 166
types of bioceramics, 154–155
Glaucoma, implants for, 589–590
Glucose sensing meet photonics,
biomaterials and, 805–806
Glycosaminoglycans (GAGs), 134–136,
265
Glycosaminoglycans, graft copolymers
of, 136
Golgi apparatus, 253–254
Graft copolymers of collagen, 136
Graft copolymers of glycosaminoglycans,
136
Grafts; See also Allografts; xenografts
peripheral stents and stent, 479
stents and, 476–483
vascular, 479–483
Granulation tissue, 300–301
Groups, polymers containing
hydrolyzable pendant, 416
H
HA (hydroxyapatite), clinical
applications of, 166
Hard-tissue adhesives, 579–580
Healing, wound, 296–304
Healing, wound coverage and, 602–604
Heart disease, valvular, 472–476
Heart failure, 486–490
Heart, total implantable artificial, 489
Heart valve calcification,
pathophysiology of bioprosthetic,
447–448
Heart valves, 440, 720–721
artificial, 38–40, 799–800
substitute, 472–476
HeartMate, 497–498
Hemoglobin; See also Polyhemoglobin
Hemoglobin, miscellaneous types of
soluble modified, 508–509
Hemoglobin, modified, 507–511
miscellaneous types of soluble
modified hemoglobin, 508–509
mw (molecular weight) distribution,
509
polyhemoglobin, 507–508
second-generation hemoglobin blood
substitutes, 510–511
third-generation blood substitutes, 511
in vitro biocompatibility screening test,
509–510
Hemoperfusion, 518
Heparin, ionically bound, 462–465
Heparin, thrombin inhibition without,
465
Heparinization, 462
Hierarchies, testing, 390–392
High-molecular-weight kininogen
(HMWK), 336
Hip arthroplasty, history of total,
529–532
femoral head prostheses, 531
long-stem prostheses, 531
mold arthroplasty, 529–531
short-stem prostheses, 531
total hip replacement arthroplasty,
531–532
Hip dislocation, total, 37
Hip replacement arthroplasty, total,
531–532
HMWK (high-molecular-weight
kininogen), 336
Host reactions to biomaterials,
293–354
biofilms, biomaterials and
device-related infections, 345–353
blood coagulation and blood-materials
interactions, 332–338
complement system, 318–328
immune response to foreign materials,
304–318
infection, 295–296
inflammation and wound healing,
296–304
inflammatory reaction to biomaterials,
293–294
innate and adaptive immunity,
304–318
systemic and remote effects, 294–295
systemic toxicity and hypersensitivity,
328–332
thromboembolic complications, 295
tumorigenesis, 295
tumorigenesis and biomaterials,
338–345
Human and animal tumors, implants
with, 339–341
Human plasma/blood, 505–506
Hyaluronan, proteoglycans and, 265
Hybrid bicomponent fibers, 91–92
Hydrocolloid dressings, 608
Hydrogel contact lenses, soft, 584–586
Hydrogels, 100–107
applications, 104–106
classification and basic structure,
100–101
complexation, 105
complexing, 104
determination of structural
characteristics, 103
intelligent or smart, 103–104
pH-sensitive, 103, 105
preparation, 101–102
properties of important biomedical,
103
swelling behavior, 102–103
temperature sensitive, 104
temperature-sensitive, 105
Hydrolysis-preclinical and clinical
experience, 414–416
poly(alkyl cyanoacrylates), 416
polyamides, 415–416
poly(ester urethanes), 415
polyesters, 414–415
polymers containing hydrolyzable
pendant groups, 416840 INDEX
Hydrolytic biodegradation, 412–416
host-induced hydrolytic processes,
413–414
hydrolysis-preclinical and clinical
experience, 414–416
structures of hydrolyzable polymers,
412–413
Hydrolyzable pendant groups, polymers
containing, 416
Hydrophilic effect, 61–62
Hydrophobic effect, 60–61
Hypersensitivity
and immunotoxicity, 330
systemic toxicity and, 328–332
I
IABPs (intraaortic balloon pumps), 487
ICDs (implantable
cardioverter-defibrillators), 485
ICDs, pacemakers and, 479–481
Imaging
digital, 404–406
low-voltage, 408
molecular, 809
Immune response to foreign materials,
304–318
Immune responses, pathology associated
with, 311–317
pathogenesis of antibody-mediated
disease, 313–314
pathogenesis of cell-mediated disease,
314–317
Immunity
innate and adaptive, 304–318
recognition and effector pathways in
adaptive, 307–311
recognition and effector pathways in
innate, 306–309
types of adaptive, 309
Immunoisolation, 728–734
applications, 733
challenge of, 728–729
Immunoisolation, devices for, 729–733
cells, 732
matrices, 732
membranes, 731–732
Immunologic toxicity of medical devices,
327
Immunoreagents, solid phase, 695–696
Immunotoxicity, hypersensitivity and,
326
Implant and device failure, 760–765
biological testing of implants, 763
design, 762
packaging, shipping, and storage, 764
patient/user, 764
raw materials, fabrication, and
sterilization, 763–764
testing of materials/design
configurations, 762–763
Implant modalities, currently used,
559–566
Implant retrieval and evaluation,
771–780
approach to assessment of host,
774–776
components of implant retrieval and
evaluation, 773–774
goals, 772–773
implanting responses, 774–776
role of implant retrieval in device
development, 776–777
useful information learned from
implant retrieval, 777–780
Implant retrieval and evaluation in
research, 753
correlation, surfaces and biomaterials
science, 765–771
implant and device failure, 760–765
implant retrieval and evaluation,
771–780
sterilization of implants and devices,
754–760
Implant retrieval, role of, 775–776
Implant retrieval, useful information
learned from, 777–780
Implantable artificial heart, total, 489
Implantable cardioverter-defibrillators
(ICDs), 485
Implantation, dental, 555–572
clinical environment, 567–569
currently used implant modalities,
559–566
general aspects of packaging and
preparation, 570
history, 555–559
tissue interfaces, 566–567
trends in research and development,
569–570
Implantation, ion beam, 207–208
Implants
biological testing of, 757
breast, 441–442
cardiovascular, 771–772
chemical compositions of metals used
for, 823–824
classification of degradable medical,
121–123
corneal, 587–589
for glaucoma, 589–590
with human and animal tumors,
339–341
pyrolytic carbon for long-term
medical, 168–180
for retinal detachment surgery, 589
silicone breast, 801–802
Implants and devices, sterilization of,
754–760
challenges to biomedical specialists,
760
EO sterilization, 757–758
miscellaneous sterilization processes,
759–760
overview of sterilization methods, 756
radiation sterilization, 758–759
steam sterilization, 754–757
sterility as a concept, 754–755
sterilization process development and
validation, 755–756
Implants, intracorneal, 588
Implants, intraocular lens, 589
biomaterials for IOLs, 592–597
emerging functional variations of
IOLs, 592
future of IOLs, 599–600
introduction to cataracts, 591–592
introduction to intraocular lens
implants, 591–592
introduction to optics of eye, 591–592
IOLs with variations of optical
function, 597–599
successfulness of IOLs, 592
Implants, steps in fabrication of,
138–141
metal-containing ore to raw metal
product, 138–139
raw metal product to stock metal
shapes, 139
stock metal shapes to final metal
devices, 139–141
stock metal shapes to preliminary
metal devices, 139–141
Imprinted surfaces, molecularly,690–691
In situ gelling and in situ precipitating
delivery systems, 638
In situ polymerization, 739–740
In vitro assessment of tissue
compatibility, 356–360
assay methods, 357–359
background concepts, 356–357
clinical use, 359–360
historical overview, 356
new research directions, 360
In vitro biocompatibility screening test,
509–510
In vitro tests, 786–787
of BMIs, 370–371
In vivo
applications, 97–99
evaluation of devices, 376–377
long-term testing, 787
In vivo assessment of tissue
compatibility, 360–367
biomaterial and device perspectives in
in vivo testing, 361–362INDEX 841
perspectives on in vivo medical device
testing, 365–366
selection of animal models for in vivo
tests, 364–365
specific biological properties assessed
by in vivo tests, 362–364
in vivo tests according to intended use,
361
In vivo medical device testing,
perspectives on, 365–366
In vivo testing, short-term, 787
In vivo tests
of BMIs, 375–376
selection of animal models for,
364–365
specific biological properties assessed
by, 362–364
Induction, tissue, 737
Industrial support for research, 794–797
Inert crystalline ceramics, nearly,
158–159
Inert materials, 457–462
albumin coating and alkylation,
459–460
Infections, 295–296, 500–501
biofilms, biomaterials and
device-related, 345–351
Inflammation
acute, 298–299
chronic, 299–304
wound healing and foreign-body
response, 296–304
Inflammatory reaction to biomaterials,
293–294
Infrared spectroscopy (IRS), 50–51
Inhibition, steric, 695
Injection method, cell, 713
Injury, cells and cell, 246–260
apoptosis, 258–259
biosynthetic machinery, 253–254
causes of cell injury, 256–257
cell injury and regeneration, 255–256
cell specialization and differentiation,
255
cellular integrity and movement,
251–252
cytoskeleton, 251–252
energy generation, 254–255
Golgi apparatus, 253–254
lysosomes and proteasomes, 254
mitochondria, 254–255
necrosis, 258
normal cell housekeeping, 246–248
nucleus-central control, 252–253
pathogenesis of cell injury, 257
plasma membrane-protection,
248–251
responses to cell injury, 257–258
rough and smooth ER (endoplasmic
reticulum), 253–255
waste disposal, 254
Injury, tissue response to, 272–274
cell regenerative capacity, 273–274
extracellular matrix remodeling, 274
inflammation and repair, 272–273
Innate and adaptive immunity, 304–318
Innate immunity, recognition and
effector pathways in, 306–309
Inorganic glasses, 25–26
Interactions
blood coagulation and
blood-materials, 332–338
cell-biomaterial, 260–281
cell-matrix, 265
cell/tissue-biomaterials, 274–277
Interfaces, electrode-electrolyte, 650–651
Intergranular corrosion, 432
Interpolating functions, properties of,
36–37
Interpretation, three-dimensional, 280
Intraaortic balloon pumps (IABPs), 487
Intracorneal implants, 588
Intraocular lens implants, 589
biomaterials for IOLs, 592–597
emerging functional variations of
IOLs, 592
future of IOLs, 599–600
introduction to cataracts, 591–592
introduction to intraocular lens
implants, 591–592
introduction to optics of eye, 591–592
IOLs with variations of optical
function, 597–599
successfulness of IOLs, 592
Intraocular lenses, contamination of, 57
Intraocular lenses (IOLs), 592
Intrauterine contraceptive devices
(IUDs), 442
Intrauterine devices, 798–799
IOLs (intraocular lenses), 591–602
accommodative, 598–599
adjustable power, 599
biomaterials for, 592–597
emerging functional variations of, 592
future of, 605
monofocal toric, 597
multifocal, 597–598
phakic, 598
successfulness of, 592
with variations of optical function,
597–599
yellow-tinted blue blocking, 599
Ion beam implantation, 207–208
Ion etching, reactive plasma and, 219
Ionic bonding, 23
IRS (infrared spectroscopy), 50–51
ISO standard for biocompatibility
testing, 791–792
Isolation; See Immunoisolation
Isotropy, 28
IUDs (intrauterine contraceptive
devices), 442
J
Joint replacement, total, 193
K
Kidney assist, 514–518
Kinetics and nature of biomaterials
components, 328–329
Knits, 94–95
L
Lamina, macromechanics of, 187–188
Laminates, macromechanics of,
188–189
Large animal models
in cardiac research testing, 379–396
in vascular research testing, 379–396
LB (Langmuir-Blodgett) deposition,
208–209
Lectin pathway, 320
Legal aspects of biomaterials, 797–804
artificial heart valves, 799–800
Biomaterials Access Assurance Act,
803
defensive manufacturing and
marketing, 804
intrauterine devices, 798–799
liability of design engineers, 803
pacemakers, 800
pedicle screws, 800–801
preemption, 802
science in courtrooms, 802–803
silicone breast implants, 801–802
Lens implants, intraocular, 589
biomaterials for IOLs, 592–597
emerging functional variations of
IOLs, 592
future of IOLs, 605
introduction to cataracts, 591–592
introduction to intraocular lens
implants, 591–592
introduction to optics of eye, 591–592
IOLs with variations of optical
function, 597–599
successfulness of IOLs, 592
Lenses
contamination of intraocular, 57
flexible perfluoropolyether, 586
soft contact, 442
soft hydrogel contact, 584–586842 INDEX
Lenses, contact, 583–587
flexible perfluoropolyether lenses, 586
general properties, 583–584
rigid contact lenses, 586–587
soft hydrogel contact lenses, 584–586
Liability of design engineers, 803
LIGA (lithography, electroplating,
molding), 219
Ligand binding assays, materials for,
686–692
miscellaneous biosensor strategies,
691–692
molecularly imprinted surfaces,
690–691
particles, 686–690
self-assembled monolayers, 690
surface-enhanced spectroscopies, 691
Ligand immobilization on solid phases,
692–695
linker arms, 692–694
photolinking, 694–695
steric inhibition, 695
Light microscopy, 277–279, 397–398
Linker arms, 692–694
Liver, 710
Long-stem prostheses, 532
Long-term testing in vivo, 787
Lost tissue or organ function, replacing,
713–714
Low-voltage imaging, 408
Lower cervical spine, finite element
model for, 37–38
Lung substitutes and assist, 524
Lysosomes and proteasomes, 254
M
Macromechanics
of lamina, 187–188
of laminates, 188–189
Manufacturing, defensive, 804
Marketing, defensive manufacturing
and, 804
Materials
bioresorbable and bioerodible,
115–127
blood contacting, 495–498
bulk properties of, 23–32
dental, 809
immune response to foreign, 304–318
methods for modifying surfaces of,
203–213
organ rejection and response to
synthetic, 317–318
scaffold, 736–737
self-assembled, 806
water and biological response to,
63–64
Materials, classes used in medicine,
66–232
natural materials, 127–137
polymers, 66–78
Materials, degradation of, 411–453
degradation of polymers, 411–430
degradative effects on metals and
ceramics, 430–439
pathological calcification of
biomaterials, 439–451
Materials/design configurations, testing
of, 762–763
Materials, important properties of,
31–32
effect of fabrication on strength, 32
fatigue, 31
toughness, 32
Materials, inert, 457–462
albumin coating and alkylation,
459–460
Materials market, orthopedic, 527–529
Materials, mechanical properties of,
26–28
elastic behavior, 27
elastic constants, 28
isotropy, 28
shear, 27
stress and strain, 27
tension and compression, 27
Materials, methods for modifying
surfaces of
chemical reaction, 203
conversion coatings, 212
high-temperature and high-energy
plasma treatments, 206
ion beam implantation, 207–208
laser methods, 213
LB (Langmuir-Blodgett) deposition,
208–209
multilayer polyelectrolyte absorption,
210–211
nature of plasma environment, 206
parylene coatings, 212–213
production of plasma environments for
deposition, 206
radiation grafting and photografting,
203–205
RFGD plasma depositing gas
processes, 205–206
RFGD plasmas for immobilization of
molecules, 206
SAMs (self-assembled monolayers),
209–210
silanization, 206–207
SMAs (surface-modifying additives),
211–212
Materials, natural, 127–137
biological consequences of collagen,
132–134
chemical modification of collagen,
132–134
elastin, 136
GAG (proteoglycans and
glycosaminoglycans), 134–136
graft copolymers of collagen, 136
graft copolymers of
glycosaminoglycans, 136
physical modification of collagen,
130–132
structure of native collagen, 128–130
Materials, properties of, 23–65
bulk properties of materials, 23–32
finite element analysis, 32–40
important properties of materials,
31–32
mechanical properties of materials,
26–28
mechanical testing, 28–31
role of water in biomaterials, 59–64
surface characterization of materials,
40–59
surface properties of materials, 40–59
Materials, properties of soft, 819–821
Materials, surface characterization of,
40–59
general surface considerations and
definitions, 40–42
parameters to be measured, 42
studies with surface methods, 56–57
Materials, surface properties of, 40–59
Materials, textured and porous, 218–224
assessment of surface microtexture,
219–220
biological effects of surface
microtexture, 221–223
characterization of surface
topography, 220–221
definition of surface irregularities, 218
porosity, 218
preparation of surface microtexture,
218–219
Matrices, 732
amorphous, 265
extracellular, 260–281
Matrix composites, absorbable, 190
Matrix systems, 183–184
Mechanics; See Biomechanics;
macromechanics; micromechanics
Mechanical forces on cells, 282–287
Mechanical testing, 28–31
brittle fracture, 29
creep and viscous flow, 30–31
elasticity, 29
plastic deformation, 29–30
Mechanisms, adverse effects of defense,
329–330
Medical applications of silicones,
698–708INDEX 843
Medical device performance,
biocompatibility and, 765–766
Medical device testing, perspectives on
in vivo, 365–366
Medical devices
changes to regulated, 792–793
immunologic toxicity of, 331
Medical fibers, 87–94
absorbable synthetic fibers, 90
hybrid bicomponent fibers, 91–92
modified natural fibers, 90–91
synthetic fibers, 87–90
Medical fibers and biotextiles, 86–100
medical fibers, 87–94
processing and finishing, 94
testing and evaluation, 94–95
Medical fibers and
biotextiles-applications, 95–99
drapes and protective apparel, 96–97
topical and percutaneous applications,
97
Medical fibers and
biotextiles-construction, 92–94
braids, 94
knits, 93–94
nonwovens, 92
woven fabrics, 92–94
Medical implants
classification of degradable, 121–123
pyrolytic carbon for long-term,
168–180
Medical products, development and
regulation of, 787–792
adoption of international standards for
quality, 789
CE Mark, 790
changes to regulated medical devices,
792–793
clinical trials of unapproved devices,
790–791
combination products, 788
design control, 789–790
global regulatory strategy, 788–789
intended use, 788–789
ISO standard for biocompatibility
testing, 791–792
manufacturing controls, 790
premarket approval and clearance, 790
risk analysis, 789–790
shelf-life and aging, 792
Medicine and dentistry, application of
materials in, 455–707
adhesives and sealants, 572–583
artificial red blood cell substitutes,
507–514
bioelectrodes, 649–656
biomedical sensors and biosensors, 670
burn dressings and skin substitutes,
602–614
cochlear prostheses, 658–669
DDS (drug delivery systems), 628–648
diagnostics and biomaterials, 685–697
extracorporeal artificial organs,
514–526
implantable cardiac assist devices,
494–507
intraocular lens implants, 589–602
medical applications of silicones,
698–708
nonthrombogenic treatments and
strategies, 456–470
ophthalmological applications,
583–591
orthopedic applications, 526–555
strategies to lower thrombogenicity of
metals, 466
sutures, 614–628
use of endothelial cells and RGD
peptides, 466
Medicine, classes of materials used in,
66–232
applications of smart polymers as
biomaterials, 107–115
bioresorbable and bioerodible
materials, 115–127
ceramics, glasses and glass-ceramics,
153–168
composites, 180–196
hydrogels, 100–107
medical fibers and biotextiles, 86–101
metals, 137–153
natural materials, 127–137
nonfouling surfaces, 196–200
physicochemical surface modification
of materials used in medicine,
200–217
pyrolytic carbon for long-term medical
implants, 168–180
silicone biomaterials-history and
chemistry, 79–86
surface-immobilized biomolecules,
225–233
textured and porous materials,
218–224
Medicine, materials used in, 200–217
general principles, 200–202
methods for modifying surfaces of
materials, 203–213
patterning, 213–214
Medicine, sensors in modern, 670
Melt spinning, 87–88
Membrane attack complex, 318
Membrane plasma filtration, 522–523
Membrane plasma separation, 520–522
Membranes
cells combined with synthetic, 608
plasma, 248–251
synthetic, 613
Mesoderm, 718–722
Metabolic products of diseased tissues or
organs, 712
Metallic bonding, 24–25
Metallic corrosion, 432–434
Metals, 25, 137–153, 535–557
cobalt-chromium alloys, 536–537
microstructures and property of
implant metals, 141–151
stainless steel alloys, 536
steps in fabrication of implants,
138–141
titanium alloys, 537
Metals and ceramics, degradative effects
on, 430–439
Metals, degradation effects on, 430
ceramic degradation, 437–438
corrosion and corrosion control,
434–437
influence of biological environment,
434
Metals, microstructures and property of
implant, 141–151
cobalt-based alloys, 144–148
stainless steels, 141–143
titanium-based alloys, 148–151
Metals, strategies to lower
thrombogenicity of, 466
Metals used for implants, chemical
compositions of, 822–823
Methods
assay, 357–359
cell injection, 713
closed-system, 713
contact angle, 44–45
for modifying surfaces of materials,
203–213
overview of finite element, 33–35
overview of sterilization, 754
studies with surface, 56–57
Microbiology, biofilm, 346–349
bacterial adhesion to surfaces, 347
biofilm formation on surfaces,
347–348
engineering approaches to biofilm
control, 349
natural control of biofilm formation
on surfaces, 348–349
Microcontact printing, 219
Micromechanics, 187
Microscopy
fluorescence, 402–406
light, 277–279, 397–406
scanning probe, 51–54
Microscopy, electron, 279–280,
406–408
elemental analysis in SEM, 408
focused ion beam instruments, 408844 INDEX
Microscopy, electron (Continued)
low-voltage imaging, 408
SEM (scanning electron microscopy),
406–408
variable pressure and ESEM, 408
Microscopy for biomaterials science,
396–409
configurations, 396–397
digital imaging, 404–406
electron microscopy, 404–406
fluorescence microscopy, 402–404
light microscopy, 397–406
magnification, resolution, and
contrast, 396
Microstructures, 26
Microstructures and property of implant
metals, 141–151
cobalt-based alloys, 144–148
stainless steels, 141–143
titanium-based alloys, 148–151
Microtexture
assessment of surface, 219–220
preparation of surface, 218–219
Microtexture, biological effects of
surface, 221–223
hypotheses on contact guidance, 222
in vitro effect of surface
microtexturing, 222
in vivo effect of surface
microtexturing, 222–223
Mitochondria, 254–255
Modern medicine, sensors in, 669
Modified hemoglobin, types of soluble,
508–509
Modified natural fibers, 90–91
Mold arthroplasty, 529–531
Molding, compression, 741
Molecular imaging, 808
Molecular spreading events, 240–243
Molecular weight, 68, 74–75
Molecularly imprinted surfaces,
690–691
Molecules; See also Biomolecules
adaptor/adhesive, 270
delivery of bioactive, 740
Monolayers, self-assembled, 690
Multifocal IOLs, 597–598
Multilayer polyelectrolyte absorption,
210–211
Multivariate correlation, 769–770
Muscle, 719–720
Mw (molecular weight) distribution, 505
N
Native collagen, structure of, 128–130
Natural biomaterials, lack of pure and
safe, 806
Natural fibers, modified, 90–91
Natural materials, 127–137
biological consequences of collagen,
132–134
chemical modification of collagen,
132–134
elastin, 136
GAG (proteoglycans and
glycosaminoglycans), 134–136
graft copolymers of collagen, 136
graft copolymers of
glycosaminoglycans, 136
physical modification of collagen,
130–132
structure of native collagen, 128–130
Natural sutures, 616–617
Necrosis, 258
Needles, 623–624
Nervous system, 714–715
Neuronal electrode arrays, 808
New
alloys and surface coatings, 537–539
cobalt alloys, 538–539
stainless steels, 539
titanium alloys, 538
zirconium and tantalum alloys,
537–538
New biomaterials, ethical issues in
development of, 793–797
New products and standards, 783–784
development and regulation of medical
products, 788–793
ethical issues in development of new
biomaterials, 793–797
legal aspects of biomaterials, 797–804
voluntary consensus standards,
783–788
Nonabsorbable sutures, synthetic,
617–618
Nonconsuming sensors, consuming
versus, 671–672
Noncontact profilometry, 221
Nonfouling surfaces (NFSs),
196–200
Nonthrombogenic treatments and
strategies, 456–470
active materials, 462–466
criteria for nonthrombogenicity,
456–457
inert materials, 457–462
Nonthrombogenicity, criteria for,
456–457
Nonwovens, 92
Normal tissues, structure and function
of, 260–272
basic tissues, 265–268
cell-matrix interactions, 265
ECM (extracellular matrix), 262–265
need for tissue perfusion, 260–262
organs, 268–272
Novacor, 496–497
Nucleic acid delivery systems, 641–642
Nucleus-central control, 252–253
O
Ophthalmological applications, 583–591
contact lenses, 583–587
corneal implants, 587–589
implants for glaucoma, 589–590
implants for retinal detachment
surgery, 589–590
intraocular lens implants, 589
surgical adhesives, 590
Optical function, IOLs with variations
of, 597–599
Optics of eye, introduction to, 591–592
Organ function, replacing lost tissue or,
713–714
Organ function, therapeutic approaches
for lost tissue or, 712
artificial prosthesis, 712
metabolic products of diseased tissues
or organs, 712
surgical reconstruction, 712
transplantation, 712
Organ rejection and response to
synthetic materials, 317–318
Organs, 266–270
metabolic products of diseased tissues
or, 712
Organs, artificial, 709–749
immunoisolation, 728–734
overview of tissue engineering,
712–728
synthetic bioresorbable polymer
scaffolds, 735–749
Organs, extracorporeal artificial,
514–526
apheresis, 518–524
bioartificial devices, 525
development of extracorporeal
artificial organs, 525
kidney assist, 514–518
lung substitutes and assist, 524
Orthopedic and dental implants,
779–780
Orthopedic applications, 526–555
history of total hip arthroplasty,
529–532
orthopedic biomaterials, 528
orthopedic biomaterials design, 528
orthopedic biomaterials market,
526–528
structure and properties of calcified
tissues, 528–529
total hip arthroplasty-current
technology, 532–539INDEX 845
Orthopedic biomaterial corrosion,
541–543
corrosion mechanisms, 543
corrosion of joint replacements,
542–543
passivating oxide films, 541–542
Orthopedic biomaterial wear, 540–541
Orthopedic biomaterials, 528
Orthopedic biomaterials-clinical
concerns, 539–553
carcinogenesis, 551–552
effects of wear and corrosion, 546–551
local tissue effects of wear and
corrosion, 543–546
orthopedic biomaterial corrosion,
541–543
orthopedic biomaterial wear, 540–541
preventive strategies and future
directions, 552–553
Orthopedic biomaterials design, 528
Orthopedic biomaterials market,
526–528
Oxidation reaction mechanisms and
polymer structures, 416–418
Oxidative biodegradation, 416–427
device- or environment-mediated
oxidation, 421–425
direct oxidation by host, 418–421
oxidation reaction and polymer
structures, 416–418
oxidative degradation and external
environment, 425–427
P
Pacemakers, 800
cardiac, 483–485
and ICDs, 483–485
Pancreas, 716–717
Particles, 686–690
Particulate composites, 189–190
Particulate systems, 642–645
Parylene coatings, 212–213
Patents, 796–797
Pathobiology of foreign body
tumorigenesis, 341–344
Pathogenesis
of antibody-mediated disease, 313–314
of cell-mediated disease, 314–317
Pathological calcification of
biomaterials, 439–451
assessment of biomaterials
calcification, 442–444
pathologic biomaterials, 440–442
pathophysiology, 444–448
prevention of calcification, 448–451
Pathology associated with immune
responses, 311–317
Pathophysiology, 444–448
Pathway, classical, 319–320
Pathway, lectin, 320
Patterning, 213–214
PCL (polycaprolactone), 118
PDS (polydioxanone), 117
Pedicle screws, 800–801
Pendant groups, hydrolyzable, 416
Peptides, RGD, 466
Perfluorochemicals, 511–512
Perfluoropolyether lenses, flexible,
586–587
Performance, biocompatibility and
medical device, 765–766
Perfusion, need for tissue, 260–262
Peripheral stents and stent grafts, 479
Permanent skin substitutes, 609–613
PH-sensitive hydrogels, 103, 105
Phakic IOLs, 598
Phase separation, 743
PHB (poly(hydroxybutyrate)), 117
Phosphate ceramics, calcium, 162–165
Phosphate coatings, calcium, 165–166
Phosphates, resorbable calcium, 166
Photonics, biomaterials and glucose
sensing meet, 805–806
PHV (poly(hydroxyvalerate)), 117
Physical sensors, 675–676
Physical versus chemical sensors, 670
Physicochemical surface modification of
materials, 200–217
general principles, 200–202
methods for modifying surfaces of
materials, 203–213
patterning, 213–214
Pitting corrosion, 435
Plasma/blood, human, 509–510
Plasma environment, nature of, 206
Plasma exchange, 518–519
Plasma filtration, membrane, 522–523
Plasma fractionation, sorption, 523
Plasma membranes, 248–251
Plasma, reactive, 219
Plasma separation
centrifugal, 519–520
membrane, 520–522
Plastic corneas, 588
Plastic deformation, 29–30
Platelets; See also Anti-platelets
adhesion, 333
aggregation, 333–334
coagulant activities, 334
consumption, 56–57, 334
release reactions, 334
Poly(alkyl cyanoacrylates), 416
Polyamides, 415–416
Poly(amino acids), 119–121
Polyanhydrides, 119
Polycaprolactone (PCL), 118
Polycyanoacrylates, 120
Polydioxanone (PDS), 117
Polyelectrolyte absorption, multilayer,
210–211
Poly(ester urethanes), 415
Poly(ethylene glycol), 105
Poly(glycolic acid), 120
degradation studied by SIMS, 57
Polyhemoglobin, 507–508
Poly(lactic acid), 120
Polymer and fiber selection, 89–90
Polymer fibers, 182–183
Polymer scaffolds, synthetic
bioresorbable, 735–749
applications of scaffolds, 737–740
cell seeding and culture in 3D
scaffolds, 745–746
characterization of processed scaffolds,
745
scaffold design, 735–736
scaffold materials, 736–737
scaffold processing techniques,
740–744
Polymer structures, oxidation reaction
and, 416–418
Polymer therapeutic delivery systems,
640–641
Polymeric biomaterials, 78–79
biodegradable polymers, 79
copolymers, 79
Polymeric bladders in blood pumps,
440–441
Polymerization, in situ, 739–740
Polymers, application of smart
smart polymer-protein bioconjugates
in solution, 109–110
smart polymers in solution, 108–109
smart polymers on surfaces, 110
Polymers, applications of smart,
107–115
smart gels that respond to biological
stimuli, 112
smart polymer bioconjugates on
surfaces, 110–111
smart polymer hydrogels with stimuli,
111–112
Polymers as biomaterials, synthetic
degradable, 121–125
Polymers, characterization techniques,
74–77
determination of molecular weight,
74–75
determination of structure, 75
mechanical and thermal property
studies, 75–77
surface characterization, 77
Polymers, chemical and biochemical
degradation of, 411–430
hydrolytic biodegradation, 412–414
oxidative biodegradation, 416–427846 INDEX
Polymers, chemical and biochemical
degradation of (Continued)
polymer degradation processes,
411–412
Polymers, currently available degradable,
116–121
poly(amino acids), 119–121
pseudo-poly(amino acids), 119–121
Polymers; See also Biopolymers;
copolymers, 26, 67–79, 533–534
biodegradable, 79
containing hydrolyzable pendant
groups, 416
fabrication and processing, 77
molecular weight, 68
polymeric biomaterials, 78–79
silicone, 80–83
star, 106
synthesis, 68–69
Polymers – solid state, 70–74
copolymers, 74
crystallinity, 73
mechanical properties, 73
tacticity, 70–73
thermal properties, 74
Poly(ortho esters), 119
Polyphosphazenes, 120
Poly(vinyl alcohol), 105
Porous ceramics, 158–159
Porous materials, textured and, 218–224
Preemption, 802
Prevascularization, 738–739
Printing, microcontact, 219
Processed scaffolds, characterization of,
745
Processes
closed-mold, 186
filament-winding, 186
miscellaneous sterilization, 759–760
vacuum bag-autoclave, 185
Products, development and regulation of
medical, 788–793
adoption of international standards for
quality, 789
CE Mark, 790
changes to regulated medical devices,
792–793
clinical trials of unapproved devices,
790–791
combination products, 788
design control, 789–790
global regulatory strategy, 788–789
intended use, 788–789
ISO standard for biocompatibility
testing, 791–792
manufacturing controls, 790
premarket approval and clearance, 790
risk analysis, 789–790
shelf-life and aging, 792
Products, new, 783–804
development and regulation of medical
products, 788–793
ethical issues in development of new
biomaterials, 793–797
legal aspects of biomaterials, 797–804
voluntary consensus standards,
783–788
Profilometry
contact, 220
noncontact, 221
Profusion culture, 746
Progenitor cells, circulating endothelial,
809
Prostheses
artificial, 712
femoral head, 531
loan-stem, 531
short stem, 531
urinary, 442
Prostheses, cochlear, 658–669
directions for future, 667
materials and electrode arrays,
661–666
overview of auditory system,
658–659
Proteasomes, lysosomes and, 254
Protective apparel, drapes and, 96–97
Protein bioconjugates in solution,
109–110
Protein identification, SIMS for
adsorbed, 57
Proteins
adsorbed in tissue response to
biomaterials, 237–246, 240–242
changes in adsorbed, 242–245
effects of adhesion, 238–240
Proteins in tissue, adsorbed
adsorption behavior of proteins at
solid/liquid interfaces, 240–242
conformational and biological
changes, 242–245
effects of adhesion proteins on cellular
interactions, 238–240
importance of adsorbed proteins in
biomaterials, 245
molecular spreading events, 242–245
Proteoglycans and hyaluronan, 265
Pumps
for chronic circulatory support,
502–505
polymeric bladders in blood, 440–441
PyC (pyrolytic carbon), 169–173
mechanical properties, 171–173
structure of, 171
Pyrolytic carbon, 38
Pyrolytic carbon, biocompatibility of,
177–179
Pyrolytic carbon components, steps in
fabrication of, 173–177
assembly, 176
cleaning and surface chemistry,
176–177
coating, 174–175
machine to size, 175
polish, 175–176
preform, 174
substrate material, 173–174
Pyrolytic carbon for long-term medical
implants, 168–180
R
Radiation sterilization, 758–759
60Co sterilization, 758
applications – advantages and
disadvantages, 759
electron beam sterilization, 759
process and mechanism of action,
758–759
Radio-frequency glow discharge
(RFGD), 203
Raw materials, fabrication, and
sterilization, 763–764
Reactions
foreign-body, 301–302
host, 293–354
platelet release, 334
Reactive plasma and ion
etching, 219
Receptors, complement, 324–325
Reconstruction, surgical, 712
Red blood cell substitutes, artificial,
507–514
Red cells, 338
Regulated delivery systems, 642–644
Regulated medical devices, changes to,
792–793
Regulation, 795–796
Release reaction, platelet, 334
Replacements
total hip, 531–532
total joint, 193
vascular, 440
Research, implant retrieval and
evaluation in, 753
correlation, surfaces and biomaterials
science, 762–771
implant and device failure, 760–765
implant retrieval and evaluation,
771–780
overview of sterilization methods, 756
sterilization of implants and devices,
754–760
Research, industrial support for,
794–797INDEX 847
Research testing
large animal models in cardiac,
379–396
large animal models in vascular,
379–396
Residual approach, weighted, 36
Resorbable calcium phosphates, 166
Responses, pathology associated with
immune, 311–317
Retinal detachment surgery, implants
for, 589
Retrieval and evaluation, implant, 753,
771–780
Retrieval, information learned from
implant, 777–780
RFGD plasma depositing and gas
processes, 205–206
RFGD (radio-frequency glow discharge),
203
RGD peptides, 466
Rotary blood pumps, 502–505
Rotary vessel culture, 746
S
SAMs (self-assembled monolayers),
209–210, 690
Scaffold biomaterials, tissue engineering
using, 714
Scaffold design, 735–736
Scaffold materials, 736–737
Scaffold processing techniques,
740–744
compression molding, 742
extrusion, 742–743
fiber bonding, 740
freeze-drying, 743
gas foaming (GF), 744
phase separation, 743
solid freeform fabrication (SFF), 744
solvent casting and particulate leaching
(SC/PL), 741–742
superstructure engineering, 742
Scaffolds
cell seeding and culture in 3D,
745–746
characterization of processed, 745
synthetic bioresorbable polymer,
735–749
Scaffolds, applications of, 737–740
cell transplantation, 737–738
delivery of bioactive molecules, 740
prevascularization, 738–739
in situ polymerization, 739–740
tissue induction, 737
Scaffolds, cell seeding and culture in 3D,
745–746
miscellaneous culture conditions, 746
profusion culture, 746
rotary vessel culture, 746
spinner flask culture, 745–746
static culture, 745
Scaffolds, synthetic bioresorbable
polymer, 735–749
applications of scaffolds, 737–740
cell seeding and culture in 3D
scaffolds, 745–746
characterization of processed scaffolds,
745
scaffold design, 735–736
scaffold materials, 736–737
Scanning electron microscopy (SEM), 50,
406–408
Scanning probe microscopies, 51–54
Scanning tunneling microscopy (STM),
51–54
Science in courtrooms, 802–803
Science, possibilities in biomaterials,
805–829
biocompatibility, 809–810
biomaterials and glucose sensing meet
photonics, 805–806
circulating endothelial progenitor cells,
809
dental materials, 809
DNA technologies, 807
ethics, 810
gene expression analysis, 810
lack of pure and safe natural
biomaterials, 806
miscellaneous stem cells, 809
molecular imaging, 809
neuronal electrode arrays, 808
novel elastic and smart biopolymers,
808
self-assembled materials, 806
silk as biomaterial, 807–808
Screening test, in vitro biocompatibility,
509–510
Screws, pedicle, 800–801
Sealants, adhesives and, 572–583
background concepts, 573–576
characteristics of adhesive
biomaterials, 576–581
composition of adhesive biomaterials,
576–581
historical overview, 572–573
new research directions, 581–582
Self-assembled materials, 805
Self-assembled monolayers (SAMs),
209–210, 690
Self-assembled structures, 106
SEM, elemental analysis in, 408
SEM (scanning electron microscopy), 50,
406–408
Sensors
chemical, 676–679
in modern medicine, 670
physical, 675–676
physical versus chemical, 670
Sensors and biosensors, biomedical, 670
biocompatibility, 673–674
biosensors, 679–683
classes of sensors, 674–679
consuming versus nonconsuming
sensors, 671–672
duration of use, 672–673
interaction of sensor with its
environment, 671
micrototal analytical systems, 683–684
physical versus chemical sensors, 670
sensors in modern medicine, 670
site of measurement, 672
Sensors, classes of, 674–679
chemical sensors, 676–679
new technologies, 674–675
physical sensors, 675–676
Sensors, consuming versus
nonconsuming, 671–672
Separation
centrifugal plasma, 519–520
membrane plasma, 520–522
phase, 743
Shear, 27
Sheep, 384–386
Short-fiber composites, 189
Short-stem prostheses, 531
Short-term in vivo testing, 781
Silicone biomaterials-history and
chemistry, 80–86
chemical structure and nomenclature,
80–86
historical milestones in silicone
chemistry, 80
nomenclature, 80
physicochemical properties, 85–86
preparation, 80–85
silicone polymers, 80–83
Silicone breast implants, 801–802
Silicone elastomers, 83–85
cross-linking by addition, 84
cross-linking by condensation, 83–84
cross-linking with radicals, 83
elastomer filler, 84–85
Silicone polymers, 80–83
Silicones, medical applications of,
698–708
aesthetic implants, 703–705
biocompatibility, 705–706
biodurability, 706–707
catheters, drains, and shunts, 700–702
orthopedic applications of silicone,
700
Silk as biomaterial, 807–808
SIMS for adsorbed protein
identification, 57848 INDEX
SIMS, poly(glycolic acid) degradation
studied by, 57
SIMS (secondary ion mass spectrometry),
46–50
Skeleton; See also Cytoskeleton
Skeletal cell responses to mechanical
forces, 285–287
Skin, 715–716
Skin substitutes, burn dressings and,
602–613
advances in burn treatment, 602
permanent skin substitutes, 609–613
wound coverage and healing,
602–605
temporary skin substitutes, 605–609
wound coverage and skin substitutes,
604–605
Skin substitutes, permanent, 609–613
Skin substitutes, temporary, 605–609
Skin substitutes, wound coverage and,
604–605
Smart gels that respond to biological
stimuli, 112
Smart polymer bioconjugates on
surfaces, site-specific, 110–111
Smart polymers as biomaterials,
applications of, 107–115
smart gels that respond to biological
stimuli, 112
smart polymer bioconjugates on
surfaces, 110–111
smart polymer hydrogels, 111–112
smart polymer-protein bioconjugates
in solution, 109–110
smart polymers in solution, 108–109
smart polymers on surfaces, 110
SMAs (surface-modifying additives),
211–212
Soft contact lenses, 438
Soft hydrogel contact lenses,
584–586
Soft materials, properties of, 819–821
Soft-tissue adhesives, 576–579
Solid/liquid interfaces, 240–242
Solid phases, ligand immobilization on,
692–695
Soluble modified hemoglobin, 508–509
Solvent casting and particulate leaching
(SC/PL), 741–742
Sorption plasma fractionation, 523
Specialists, challenges to
biomedical, 760
Species consideration, animal models
and, 381–390
Spectroscopies, surface-enhanced, 691
Spine, finite element model for lower
cervical, 37–38
Spinner flask culture, 745–746
Spinning
melt, 87–88
wet, 88
Stainless steel alloys, 536
Stainless steels, 141–143
new, 539
Standards
defined, 783–784
ISO, 791–792
users of, 784–785
Standards, biocompatibility, 786–787
long-term testing in vivo, 787
short-term in vivo testing, 787
in vitro tests, 786–787
Standards, new products and, 783–804
development and regulation of medical
products, 788–793
ethical issues in development of new
biomaterials, 793–797
legal aspects of biomaterials, 797–804
voluntary consensus standards,
783–788
Standards, voluntary consensus,
783–788
biocompatibility standards, 786–787
standards, 783–784
users of standards, 784–785
writers of standards, 785–786
Standards, writers of, 785–786
history and current structure of ASTM
F04, 785
standards development process,
785–786
Star polymers, 106
Static culture, 745
Steam sterilization, 756–757
applications—advantages and
disadvantages, 756
process and mechanism of action, 756
Steel alloys, stainless, 536
Steels
new stainless, 539
stainless, 141–143
Stem cells, miscellaneous, 809
Stent grafts, peripheral stents and, 475
Stents
coronary artery, 476–479
and grafts, 476–483
peripheral, 479
Steric inhibition, 695
Sterilization
electron beam, 759
of implants and devices, 754–760
Sterilization, EO, 757–758
advantages and disadvantages, 758
applications, 758
EO residuals issues, 758
process and mechanism of action, 757
Sterilization methods, overview of, 756
Sterilization process development and
delegation, 754–755
product and packaging compatibility,
755
sterility assurance level, 755–756
Sterilization processes, miscellaneous,
759–760
new technologies, 759–760
traditional methods, 759
Sterilization, radiation, 758–759
60Co sterilization, 758
applications-advantages and
disadvantages, 759
electron beam sterilization, 759
process and mechanism of action,
758–759
Sterilization, raw materials, fabrication
and, 763–764
Sterilization, steam, 756–757
applications—advantages and
disadvantages, 756
process and mechanism of action, 756
Stimuli, smart gels that respond to
biological, 113
STM (scanning tunneling microscopy),
51–54
Strain, stress and, 27
Strategies
miscellaneous biosensor, 691–692
nonthrombogenic treatments and,
456–470
Strength, effect of fabrication on, 32
Stress
corrosion cracking, 436
and strain, 27
Structural characteristics, determination
of, 104
Structures
atomic, 25
self-assembled, 106
tubular, 717–718
Substitutes
permanent skin, 609–613
temporary skin, 605–609
Superstructure engineering, 742
Surface analysis techniques, 42–56
AFM (atomic force microscopy),
51–54
contact angle methods, 44–45
ESCA (electron spectroscopy for
chemical analysis), 45–46
IRS (infrared spectroscopy), 50–51
newer methods, 54–56
sample preparation, 42
scanning probe microscopies, 51–54
SEM (scanning electron microscopy),
50
SIMS (secondary ion mass
spectrometry), 46–50INDEX 849
STM (scanning tunneling microscopy),
51–54
surface analysis general comments,
42–44
Surface coatings, new alloys and,
537–539
Surface composition, 56–57
Surface-enhanced spectroscopies, 691
Surface-immobilized biomolecules,
225–233
immobilization methods, 227–230
Surface methods, studies with, 56–57
contact-angle correlations, 57
contamination of intraocular lenses, 57
platelet consumption, 56–57
poly(glycolic acid) degradation studied
by SIMS, 57
SIMS for adsorbed protein
identification, 57
surface composition, 56–57
titanium, 57
Surface microtexture
assessment of, 219–220
preparation of, 218–219
Surface microtexture, biological effects
of, 221–223
hypotheses on contact guidance, 222
in vitro effect of, 222
in vivo effect of surface
microtexturing, 222–223
Surface topography, characterization of,
220–221
Surface wetting effect, 62–63
Surfaces
bacterial adhesion to, 347
biofilm formation on, 347–348
molecularly imprinted, 690–691
natural control of biofilm formation
on, 348–349
nonfouling, 196–200
properties of biomaterials and devices,
373
smart polymer bioconjugates on,
110–111
Surfaces and biomaterials science,
correlation, 765–771
aspects of bioreaction to biomaterials,
767
biocompatibility and medical device
performance, 765–766
case for correlation, 767–769
correlation, 766–767
data, information, and statistics, 766
Surgery, implants for retinal detachment,
589
Surgical adhesives, 590
Surgical reconstruction, 712
Sutures, 614–628
absorbable synthetic, 618–621
classification, 614–615
colorants, 622–623
future development, 625–626
general characteristics, 615–616
market trends, 625
natural, 616–617
needles, 623–624
packaging and sterilization, 624–625
property comparisons, 621–622
regulatory considerations, 620
suture materials, 616–621
synthetic nonabsorbable, 617–618
Swine, 382–384
Synthetic fibers, 87–90
absorbable, 90
electrospinning, 88–89
melt spinning, 87–88
polymer and fiber selection, 89–90
wet spinning, 88
Synthetic materials, organ rejection and
response to, 317–318
Synthetic membranes, 608
Synthetic nonabsorbable sutures,
617–618
Synthetic sutures, absorbable, 618–621
Systemic toxicity and hypersensitivity,
328–332
adverse effects of defense mechanisms,
329–330
allergy and biomaterials, 330
atopy, 331
hypersensitivity and immunotoxicity,
330
immunologic toxicity of medical
devices, 331
kinetics and nature of biomaterials
components, 328–329
miscellaneous interactions, 331–332
toxicodynamic considerations, 329
types of allergies, 330–331
Systems
chemically controlled delivery,
633–638
diffusion-controlled delivery, 628–631
matrix, 183–184
nervous, 714–715
nucleic acid delivery, 640
overview of auditory, 658–659
particulate, 642–645
polymer therapeutic delivery, 642
regulated delivery, 641–642
in situ gelling precipitating delivery,
638
in situ precipitating delivery, 638
water penetration-controlled delivery,
631–633
Systems, complement, 318–328
AP (alternative pathway), 320–322
classical pathway, 319–320
clinical correlates, 325–327
complement receptors, 324–325
control mechanisms, 322–324
future directions, 327
lectin pathway, 320
membrane attack complex, 322
T
Tacticity, 70–73
Tantalum alloys, new, 537–538
Techniques, surface analysis, 42–56
Technologies, DNA, 807
Temperature sensitive hydrogels, 104
Temperature-sensitive hydrogels, 105
Temporary skin substitutes, 605–609
Tension and compression, 27
Testing
large animal models in cardiac
research, 379–396
large animal models in vascular
research, 379–396
of materials/design configurations,
756–757
mechanical, 28–31
perspectives on in vivo medical device,
365–366
short-term in vivo, 787
Testing, biological, 355–409, 757
evaluation of BMIs (blood-materials
interactions), 367–379
large animal models in cardiac
research testing, 379–396
large animal models in vascular
research testing, 379–396
microscopy for biomaterials science,
396–409
Testing hierarchies, 390–392
Testing in vivo, long-term, 787
Tests
agar diffusion, 358
direct contact, 357–358
elution, 358
selection of animal models for in vivo,
364–365
specific biological properties assessed
by in vivo, 362–364
in vitro, 786–787
in vitro biocompatibility screening,
509–510
Textiles; See Biotextiles
Texture; See Microtexture
Textured and porous materials, 218–224
Therapeutic approaches for lost tissue or
organ function, 712
Thoratec, 495–496
Three-dimensional interpretation, 280850 INDEX
3D scaffolds, cell seeding and culture in,
745–746
Thrombin inhibition without heparin,
465
Thromboembolic complications, 295
Thromboembolism, 499–500
Thrombogenic treatments; See
Nonthrombogenic treatments
Thrombogenicity defined, 368–370
Tissue attachment, 154–155
Tissue-biomaterials interactions; See
Cell/tissue-biomaterials interactions
Tissue compatibility, in vitro assessment
of, 356–360
assay methods, 357–359
background concepts, 356–357
clinical use, 359–360
historical overview, 356
new research directions, 360
Tissue compatibility, in vivo assessment
of, 360–367
animal models for in vivo tests,
364–365
biological properties assessed by in
vivo tests, 362–364
perspectives in in vivo testing,
361–362
perspectives on in vivo device testing,
365–366
in vivo tests according to intended use,
361
Tissue-derived biomaterials, 317–318
Tissue, ectodermal derived, 714–716
Tissue engineering, applications of,
714–716
ectodermal derived tissue, 714–716
endoderm, 716–718
mesoderm, 718–722
Tissue engineering, overview of,
712–728
applications of tissue engineering,
714–722
future perspectives, 722
lost tissue or organ function,
712–728
replacing lost tissue or organ function,
713–714
Tissue engineering using scaffold
biomaterials, 714
Tissue induction, 737
Tissue or organ function, replacing lost,
713–714
Tissue or organ function, therapeutic
approaches for lost, 712
artificial prosthesis, 712
metabolic products of diseased tissues
or organs, 712
surgical reconstruction, 712
transplantation, 712
Tissue perfusion, need for, 260–262
Tissue response
adsorbed proteins, 237–246
to biomaterials, 237–246
Tissue response to injury, 272–274
cell regenerative capacity, 273–274
extracellular matrix remodeling, 274
inflammation and repair, 272–273
Tissue sections, synthetic products in
cells or, 280
Tissues
basic, 265–268
extracellular matrix and
cell-biomaterial interactions,
260–281
granulation, 300–301
Tissues or organs, metabolic products of
diseased, 712
Tissues, structure and function of
normal, 260–272
basic tissues, 265–268
cell-matrix interactions, 265
ECM (extracellular matrix),
262–265
need for tissue perfusion, 260–262
organs, 268–272
Tissues, structure and properties of
calcified, 528–529
Tissues, techniques for analysis of cells
and, 277
artifacts, 280
electron microscopy, 279–280
functional assessment of cells, 280
light microscopy, 277–279
synthetic products in cells or tissue
sections, 280
three-dimensional interpretation, 280
Titanium, 57
Titanium alloys, 537
new, 538
Titanium-based alloys, 148–151
Topography, characterization of surface,
220–221
Total hip arthroplasty-current
technology, 532–539
ceramics, 534–535
metals, 535–557
new alloys and surface coatings,
537–539
orthopedic biomaterials-clinical
concerns, 539–553
polymers, 533–534
Total hip arthroplasty, history of,
529–532
Total hip dislocation, 37
Total hip replacement arthroplasty,
531–532
Total implantable artificial heart, 485
Total joint replacement, 193
Toughness, 32
Toxicity, immunologic, 331
Toxicity; See also Genotoxicity;
immunotoxicity
Toxicity, systemic, 328–332
adverse effects of defense mechanisms,
329–330
allergy and biomaterials, 330
atopy, 331
hypersensitivity and immunotoxicity,
330
immunologic toxicity of medical
devices, 331
kinetics and nature of biomaterials
components, 328–329
miscellaneous interactions, 331–332
toxicodynamic considerations, 329
types of allergies, 330–331
Toxicodynamic considerations, 329
Transplantation, 712
cell, 737–738
Treatments and strategies,
nonthrombogenic, 456–470
Trials, clinical, 793–794
Tubular structures, 717–718
Tumorigenesis, 295
Tumorigenesis and biomaterials,
338–345
implants with human and animal
tumors, 339–341
pathobiology of foreign body
tumorigenesis, 341–344
Tumorigenesis, pathobiology of foreign
body, 341–344
Tumors, implants with human and
animal, 339–341
U
Unapproved devices, clinical trials of,
790–791
Urinary prostheses, 442
Users of standards, 784–785
V
Vacuum bag-autoclave process, 185
VAD biocompatibility issues,
complications and, 498–506
bleeding, 501–502
infection, 500–501
mechanical failure, 506
thromboembolism, 499–500
VADs (ventricular assist devices),
494–495
Valves
artificial heart, 38–40, 793–794
heart, 440, 714–715
substitute heart, 472–476INDEX 851
Valvular heart disease, 472–476
Variational approach, 36
Variational formulation, 35–36
Vascular cell responses to mechanical
forces, 280–285
Vascular disease, atherosclerotic,
476–483
Vascular grafts, 479–483
Vascular replacements, 440
Vascularization; See Prevascularization
Ventricular assist devices, 487–489
Ventricular assist devices (VADs),
494–495
Vessel culture, rotary, 740
Vessels, blood, 714
Viscous flow, creep and,
30–31
W
Waste disposal, 254
Water and biological response to
materials, 63–64
Water penetration-controlled delivery
systems, 631–633
Water, role of in biomaterials, 59–64
hydrophilic effect, 61–62
hydrophobic effect, 60–61
surface wetting effect, 62–63
water and biological response to
materials, 63–64
water solvent properties, 59–60
Water solvent properties, 59–60
Weak bonding, 25
Wear, orthopedic biomaterial, 540–541
Weight, molecular, 68, 74–75
Weighted residual approach, 36
Wet spinning, 88
Wetting effect, surface, 62–63
White cells, 338
Wound coverage and healing, 602–605
Wound coverage and skin substitutes,
604–605
Wound healing and foreign-body
response, inflammation, 296–304
Woven fabrics, 93–95
Writers of standards, 779–780
X
Xenografts, 606–608
Z
Zirconium alloys, new, 537–538
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