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 |  موضوع: كتاب Handbook of Polymer Applications in Medicine and Medical Devices الأحد 26 نوفمبر 2023, 12:38 am | |
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Handbook of Polymer Applications in Medicine and Medical Devices
Edited by
Kayvon Modjarrad, MD, PhD
Chief, Respiratory Disease Vaccine Development,
United States National Institutes of Health
Sina Ebnesajjad, PhD
President, FluoroConsultants Group, LLC
و المحتوى كما يلي :
Table of contents
Preface
Author Biographies
1. Introduction
1.1 History
1.2 A Historical Example
1.3 Anthology Architecture
1.4 Summary
References
2. Application of Plastics in Medical Devices and Equipment
2.1 Device Industry Overview
2.2 Health-care Trends
2.3 From Legacy Materials to Advanced Specialty Polymers for Devices
2.4 Driving Trends Leading to New Material Requirements
2.5 Market Factors Affecting the Industry
2.6 Conclusion
3. Plastics Used in Medical Devices
3.1 Plastic Compositions
3.2 Medical Devices—Material Selection Process
3.3 Common Medical Device Polymers
3.4 Summary
References
4. Polymeric Biomaterials
4.1 Introduction
4.2 Polymeric Biomaterials in Ophthalmology
4.3 Polymeric Biomaterials in Orthopedics
4.4 Polymeric Biomaterials in Cardiovascular Diseases
4.5 Polymeric Biomaterials for Wound Closure
4.6 Polymeric Biomaterials in Extracorporeal Artificial Organs
4.7 Polymeric Biomaterials for Nerve Regeneration
4.8 Conclusions and Future Outlook
References
5. Biofilms, Biomaterials, and Device-Related Infections
5.1 Introduction
5.2 Bacterial Biofilms
5.3 Biofilm Microbiology and Infectious Disease
5.4 Device-Related Infection
5.5 Clinical Examples of Biofilm Infections
5.6 Prevention and Treatment
5.7 Conclusions
References
6. Adhesives for Medical and Dental Applications
6.1 Introduction
6.2 Natural Adhesives
6.3 Synthetic and Semisynthetic Adhesives
6.4 Cyanoacrylic Adhesives
6.5 Test Methods to Characterize Strength of Tissue Adhesives
6.6 Medical and Dental Applications of Adhesives
6.7 Bone Adhesives
6.8 Dental Applications of Adhesives
References
7. Silicones
7.1 Chemical Structure and Nomenclature
7.2 Conclusion
Acknowledgments
Bibliography
8. Review of Research in Cardiovascular Devices
8.1 Introduction
8.2 The Heart Diseases
8.3 The Cardiovascular Devices in Open-Heart Surgery
8.4 The Minimally Invasive Cardiology Tools
8.5 The Technology for Atrial Fibrillation
8.6 Minimally Invasive Surgery
8.7 The Minimally Invasive Valve Implantation
8.8 Support Technology for Surgery Planning
8.9 Conclusions
8.10 Acknowledgments
References
9. Endotracheal Tube and Respiratory Care
9.1 Introduction
9.2 Properties of the Endotracheal Tube
9.3 Endotracheal Tubes and Other Airway Adjuncts
9.4 Proper Safeguarding of the Airway
9.5 Maintenance of the Endotracheal Tube
9.6 Respiratory Therapies for the Intubated Patient
9.7 Conclusions
9.8 Clinical Pearls
References
10. Applications of Polyaryletheretherketone in Spinal Implants: Fusion and Motion Preservation
10.1 Introduction
10.2 Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s
10.3 CFR-PEEK Lumbar Cages: The Brantigan Cage
10.4 Threaded PEEK Lumbar Fusion Cages
10.5 Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws
10.6 Subsidence and Wear of PAEK Cages
10.7 Posterior Dynamic Stabilization Devices
10.8 Cervical and Lumbar Artificial Discs
10.9 Summary
Acknowledgments
References
11. Microbubble Applications in Biomedicine
11.1 Introduction
11.2 Microbubbles for Ultrasound Imaging
11.3 Targeted Microbubbles
11.4 Microbubbles in Drug and Gene Delivery
11.5 Microbubbles in Gene Delivery
11.6 Other Emerging Applications
11.7 Conclusion
References
12. Hydrogels in Regenerative Medicine
12.1 Introduction: Relevance of Hydrogels to Regenerative Medicine
12.2 Background and Theory
12.3 Utility in Regenerative Medicine
12.4 Applications of Hydrogels in Regenerative Medicine
12.5 Prospects and Conclusions
References
13. Biodegradable Polymers
13.1 Introduction
13.2 Biodegradable Polymer Selection Criteria
13.3 Biologically Derived Polymers
13.4 Synthetic Polymers
13.5 Combinations (Hybrids) of Synthetic and Biologically Derived Polymers
13.6 Using Polymers to Create Tissue-Engineered Products
13.7 Conclusion
References
14. Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview
14.1 History and Introduction
14.2 United States Regulations
14.3 ISO 13485 (European and Global Standard)
14.4 Other Countries
14.5 Global Harmonization Task Force (GHTF)
14.6 Applicability of the Regulations to Material Suppliers
14.7 Conclusion
References
Index
Index
Note: Page numbers followed by “f ”, “t ”, and “b” refer to figures, tables, and boxes, respectively.
A
Abdominoplasty, 119
AbioCor, 156
Acoustic wave propagation, 258259
4-Acryloyloxyethyl trimellitate anhydride
(4-AETA), 123
Adhesives, uses
cyanoacrylate adhesives
benefits and limitations of, 106t
polymerization reaction of, 105f
cyanoacrylate monomers, structures of,
104f
cyanoacrylic adhesives, 104110
medical/dental applications, 111119
in medicine and dentistry, 103104
natural adhesives, 104
for skin closure, 112
suture and tissue, 112114
synthetic/semisynthetic, 104
tissue adhesives, case studies of,
112119
Aintree intubation catheter,
199f
Airway evaluation
difficult airway, predicting, 200201
esophageal bulb detector, 201f
esophageal intubation, detection,
201203
homemade syringe device, 201f
identifying proper position, 201206
supraglottic devices, 200f
Airway exchange catheters, 199f, 210
Airway resistance, 196
algC, 8081
Alkoxysilane, 136137
Anterior lumbar interbody fusion (ALIF),
236
Antibiofilm properties, of biomaterials,
8991
Antibiotics, bioelectric effect,
9294
Appendectomies, 11
Appropriate depth, confirmation of,
203204
Artificial heart, 154155
Artificial organs RoboticallyAssisted
surgery (AORobAS) system,
184185, 184f
Aryloxyphosphazenes, 321
Asclepiades, 192
ASTM Method E 2196-02, 91
Atactic polypropene, 23
Atrial fibrillation, technology, 174175
cryoablation, 175
laser ablation, 175
microwave ablation, 175
radiofrequency used in ablation, 174175
ultrasound ablation, 175
Audible cuff leak, evaluation, 204205
Autoclave sterilization, 35, 41
Automated endoscopic system for optimal
positioning (AESOP)
disadvantages for, 181
robots replacing, 178
Zeus system, 180181
Automatic tube compensation (ATC),
217218
Avalve, simplest configuration of, 166f
B
Bacterial adherence, 8587
Bacterial biofilms
extracellular polymeric substance, 78
in orthopedic prosthetic joint infection,
8789
phenotypic heterogeneity, 78
on surgical mesh, 87
on sutures, 8587
Bacterial counts, for contaminated
lacerations, 113t
Bacterial infection, 266
Bacteriostatic behavior, 113
Baekeland, Leo, 3f
Bagby and Kuslich (BAK) technique, 233
Balloon angioplasty, 172173
Balloon valvotomy, 164
Basic local alignment search tool
(BLAST), 8485
Berlin heart, 158
Berlin Heart Excor, 160161
Biodegradable polymers, 33, 303305
biologically derived polymers,
305314
design/development of, 303
selection criteria, 304305
Bioelectric effect, 9293
to antibiotics, 9294
treating S. epidermidis, 9293
Biofilm bacteria, 78
cell-cell communication, 78
resistance of, 79
Biofilm destruction, 266
Biofilm development, key processes, 78f
Biofilm formation
nucleic acid-based detection methods,
8485
orthopedic screws, 84f
processes of, 8081
by staphylococci, 8283
Biofilm infected sutures, 86f
Biofilm infections
clinical examples of, 8589
surgical repair materials, 85
Biofilm microbiology
bacterial adhesion, to surfaces, 7980
biofilm formation, processes of, 8081
infectious disease, 7981
Biofilm-resistant biomaterials, prevention/
treatment, 8994
Biofilm structure, adaptation of, 7879
Bioinspiration, 94
Biologically derived polymers, 305314,
323
alginate, 312
aliphatic polyesters, 315319
copolymers, 315318
poly(glycolic acid), 315318
poly(lactic acid), 315318
barriers, 324325
biodegradable polyurethanes, 319320
biomimetic materials, 310
cellulose, 311
347Biologically derived polymers
(Continued)
chitosan, 313
collagen, 305307
elastin, 308
gelatin, 307308
gellan gum, 312
gels, 325
glycosaminoglycans (GAGs), 312313
hybrids of, 323
in vitro, 307
keratin, 308309
lactide enantiomers, 316f
matrices, 325
peptides and proteins, 305310
poly(amide carbonate), 322f
poly(amino acids), 321323
polyanhydrides, 320321
poly(ε-caprolactone) (PCL), 318, 318f
polyhydroxyalkanoates (PHA), 313314
polynucleotides, 314
poly(orthoesters), 319, 319f
poly(p-dioxanone) (PDS), 318
polyphosphazenes, 321
polysaccharides, 310313
proteins uses, as degradable
biomaterials, 306t
proteoglycans (PGs), 309310
‘pseudo’-poly(amino acids), 321323
segmented poly(urethane), general
structure of, 320f
silk, 309
starch, 311312
synthetic polymers, 314323
widely investigated polysaccharides,
306t
Biomaterials
antibiofilm properties of, 8991
microbial colonization control, 9192
polymeric. See Polymeric biomaterials
resist bacterial attachment/biofilm
formation, 9394
surfaces, biofilm control agents, 92
Biomedicine, microbubble applications.
See Microbubble applications, in
biomedicine
Biomimicry, 94
Bioresorbable polymer, 37
Biotinlylated microbubble targete
to streptavidin-coated surface, 261f
Bisphenol A (BPA), 1718
Blalock-Taussig (B-T) shunt, 185
Blood pump support, in palliative surgery
study, 185
B-16 melanoma tumors, 263
Bone adhesives, 119
characteristics of, 120t
development of, 119
Bone glue, 119
Bone regeneration scaffold, 324f
Bronchodilators, inhaled, 219
Bronchospasm, 220
Butyl cyanoacrylate, 107108
N-Butyl-2-cyanoacrylate, 110
Bypass system aortic connector, 176
C
Cannot intubate, cannot ventilate (CICV),
210
Capnography yields quantifiable
measurements, 201202
CarboMedics, 170
Carbon fibers, 29
Carcinogenesis, 33
Cardiac devices, evolution, 146t
Cardiac surgery, 151, 181182
Cardiopulmonary bypass (CPB), 66
Cardiopulmonary resuscitation (CPR), 201
Cardiovascular devices
artificial heart, 154155
schematic diagram, 154f
blood pumps, 151162
in open-heart surgery, 151171
POLTAH design process, steps, 153f
William Kolff, in Kampen, 155f
Cardiovascular surgeons, 11
Carel’s techniques, 45
Carpentier-Edwards pericardial valve,
169170
Carpentier-Edwards PERIMOUNT
pericardial bioprosthesis, 170
Carpentier-Edwards prostheses, 167
Catheter-lock solutions (CLS), 82
CE marking declaration, 342f
Cell microencapsulation, schematic of,
286f
Center for Biofilm Engineering (CBE), 80
Central Drugs Standards Control
Organization (CDSCO), 344
Central nervous system (CNS), 67
Centrifugal pumps, 152153
Chemical sterilants, 43
Chest physiotherapy, 215216
high-frequency chest wall compression,
216
intrapulmonary percussive ventilation
(IPV), 216
percussion/postural drainage, 216
positive end-expiratory pressure
therapy, 216
Coatings, 9293
Coefficient of friction (COF), 26
Collagen, 305307
adhesives, 104
advantageous properties, 307
in vitro, 307
in vivo, 307308
Colorimetric capnometric device, 203f
Comparative tracking index (CTI), 31
Complete airway management (CAM),
214
Compression molding, 139
Computational fluid dynamics (CFD), 171
Confocal microscopy, 8990
Continuous positive airway pressure
(CPAP), 217
Conventional endoscopic instruments, 181
Coronary artery bypass graft (CABG)
surgery, 1011
Coronary artery disease, 176
Cryoablation, 175
Crystalline polymers, 49
Cuff pressure monitoring, 204
Cyanoacrylate monomer, 104105
Cyanoacrylates, 105, 115116
polymerization of, 106
tissue adhesives, 104105
benefits and limitation, 106t
commercial grades, 109110
cured loctite, typical performance of,
107t
manufacturers of, 109
medical grade, 107109
topical adhesives, 116
Cyanoacrylic acid butyl ester, 112
Cyclic di-GMP, 9192
Cystic fibrosis (CF) lung, 79
Cytotoxicity, 33
D
da Vinci S model, 182
Delrin disk, 168169
Denaturing gel gradient electrophoresis
(DGGE), 8485
Dental adhesives, 119120
applications, 119124
capability of, 120
ingredients of, 122t
methacrylic acid (MA), 121122
resin monomers, 121
Derjaguin, Landau, Verwey, and
Overbeek (DLVO) theory, 7980
Dermabond (2-octylcyanoacrylate), 110
Device-related infection, 8185
biofilm formation, 81
detection, 8384
surgical repair materials, 85
Dielectrophoresis, 287
Double-lumen endotracheal tube (DLT),
199
Dry heat sterilization, 43
Dynesys, 242243
E
Edwards-Tekna valve, 168169
Eicosamethylnonasiloxane
three-dimensional representation, 141f
348 INDEXElectrohydraulic artificial heart (EHTAH),
155156
Electromagnetic interference shielding
(EMI), 29
EndoAssist, 181
Endothelial cells (ECs), 317318
Endotracheal tube (ETT), in medicine, 192
airway adjuncts, 195200
choice of, 195196
airway emergencies, rapid response
cart, 209210
airway evaluation
difficult airway, predicting, 200201
esophageal bulb detector, 201f
esophageal intubation, detection,
201203
homemade syringe device, 201f
identifying proper position, 201206
supraglottic devices, 200f
airway resistance, 195196
American Society of Anesthesiologists
difficult airway algorithm, 211f
anatomy of, 192194
anticholinergics, 219220
automatic tube compensation, 217218
ballard closed endotracheal tube
suctioning system, 213f
biofilm accumulation, 214f
biofilm management, 214215
bronchoscopy, 213214
clinical pearls, 221222
continuous positive airway pressure
(CPAP), 217
corticosteroids, 220
cuff leaks, causes/solutions, 205t
development/properties of, 194
difficult airway cart
contents of, 212b
double-lumen endotracheal tubes,
199200
heat and moisture exchanger, 212f
inhalation
antibiotics, 220
bronchodilators, 219
inhalation drug delivery, 218219
metered-dose inhalers, 218219
nebulizers, 218
intubated patient, respiratory therapies,
215221
chest physiotherapy, 215216
mucolytic agents, 215
secretion clearance, 215216
intubating laryngeal mask airway
(ILMA)
structural comparison of, 193f
large tubes and trauma, 196
laser tubes, 197198
maintenance of, 210215
inspired gas, heat/humidity of,
210212
Mallinckrodt endobronchial tube, 198f,
199f
overcoming work of, 217218
patient, positioning of, 220221
pilot balloon of, 193194
placement
complications of, 195
physiologic effects of, 194195
potentially beneficial alternatives,
196200
preformed/reinforced tubes, 196197
pressure support, 217
proper position, identification, 201206
appropriate depth, 203204
audible cuff leak, 204205, 205t
cuff pressure monitoring, 204
placement, documentation of, 205206
properties of, 192195
Rusch Lasertubus laser-safe
endotracheal tube, 198f
stabilization of, 206209
AnchorFast system, 209f
commercially available devices, 209
emergency intubations, airway record
for, 208f
facial burns, stapling, 209
split-tape method, 208f
taping, 206209
subglottic care, 213
subglottic suctioning evac endotracheal
tubes, 198199
suctioning, 212213
supraglottic airways, 200
taperguard endotracheal tube cuff, 193f
ventilator circuits, 217218
Endotracheal tube placement, 202b
Enterococcus faecium, 110
Enzyme-linked immunosorbent array
(ELISA), 8384
Escherichia coli, 110
Esophageal variceal bleeding, 115
Ester bond, of aliphatic polyesters, 315
Ethylene oxide (EtO), 31
resistance, 41
sterilization, 38
Exopolysaccharide (EPS) fibers, 7980
Extracellular bacterial DNA (eDNA), 79
Extracorporeal membrane oxygenation
(ECMO), 152
F
Facial burns, stapling, 209
Fatigue tests
conventional standardized methods, 243
nanocrystalline diamond and steel
coronary stents, 174f
of PEEK rod systems, 243
Fiberoptic bronchoscopy
to aid therapy, 195
use of, 213214
Fibrin, 111
Fibrin sealants, 104
Fibrinogen, 104, 111
Finger-printing method, 8485
Fluorescence, 28
Fluorescence in situ hybridization (FISH),
84f
Foundation of cardiac surgery
development (FCSD), 178179
G
Gamma radiation resistance, 35, 37,
4041, 43, 46
Gastrointestinal (GI) endoscopy, 115116
bleeding from other sources, 115
closure of fistula, 115116
esophageal variceal bleeding, 115
gastric variceal bleeding, 115
peptic ulcer bleeding, 115
Gelatin hydrogels, 307308
Gelatine-resorcinol-formaldeyde (GRF),
104
Gellan gum, 312
Gene delivery, 264
Gene-activated matrix (GAM), 293
Generic-targeted microbubbles, 261262
Genetic testing, 12
Genotoxicity testing, 33
Glass transition temperatures, 141142
Glenn procedure, 185
Global harmonization task force (GHTF),
344
Glubran 2, 116
Glyceryl methacrylate (GMA), 5658
Glycosaminoglycans (GAGs), 312313
Gold
marker lines, 173174
self-assembled monolayers (SAMs), 93
standard, resistance of biomaterials,
9091
Good Clinical Practice (GCP), 343
Good manufacturing practices (GMP),
337338, 343
critical devices, 338
quality assurance programs, 338
Good Quality Practice Ordinance (GQP)
standards, 343
Green heart, 155156
H
Health-care industry, 9
Health-care trends, 1012
alternate site treatment, 1112
minimally invasive surgeries, 1011
prevention vs. treatment, 12
Heart diseases, 150151
ischemic heart disease, 151
valvular heart disease, 151
Heart failure, congestive, 150151
INDEX 349Heart pacemaker, 171
Heart prostheses, 169f
HeartSaver VAD, 158
Heart-lung machines, 151
Heat and moisture exchanger (HME),
210212
Heat shock protein (HSP) family, 287
Hemocompatibility, 33, 66
Hemolysis test, 165f
Hexafluoropropylene (HFP), 65
High consistency rubber (HCR), 139
High-consistency silicone rubbers (HCRs),
136
High-density polyethylene (HDPE), 34
High-frequency chest wall compression,
216
High pressure, low volume (HPLV),
192193
ILMAs risky, 197
silicone ETTs, 192193
structural comparison of, 193f
High volume and low pressure (HVLP)
cuff, 192193, 197
Homopolymers, 3536
Homo sapiens, 145
Hospital acquired infections (HAIs), 12
Hydrogels, in regenerative medicine, 42,
279281
applications of, 290293
hydrogel parameters, effect of, 290t
skin and wound healing, 290291
as biomaterials, 283284
cell association
cell encapsulation, 285286
promoting cell attachment, substrates,
287290
schematic diagram of, 288f
spatial patterning, 287
characterization of, 293
classification, 281
for controlled release, 284285
liver, 292
matrix-immobilized ligands, 289t
and medical technology applications,
280t
musculoskeletal, 291
neural regeneration, 291292
poly(ethylene oxide), 4t
prospects, 293294
regenerative medicine, utility in, 282290
relevance of, 279281
reproductive medicine, 292293
theory, 281282
Hydroxy ethyl methacrylate (HEMA), 56,
123
of artificial heart, 154f
homopolymer of, 123
hydrolysis of, 122123, 123f
Hypoperfusion, 151
Hypoxemia, 212213
I
IgG human antibodies, 79
Impact copolymers, 3536
Impact modifiers, 2728
Implant materials, in rats, 9192
Incor device, 161
Injection molding, 139
Interpenetrating polymer networks (IPNs),
60
dimethylacrylate, 285
poly(dimethylsiloxane) (PDMS), 60
poly(ethylene glycol) (PEG), 60
Intra-aortic balloon pump (IABP),
152153
Intraocular lenses (IOLs), 56
Intrapulmonary percussive ventilation
(IPV), 216
Intubating laryngeal mask airway (ILMA)
difficult airway cart, 212b
structural comparison, 193f
Investigational device exemption (IDE)
clinical trial, 233
Investigational new animal exemptions
(INAD), 340
Irritation tests, 33
Ischemic heart disease, 151
Isomers, 2224
geometric, 2223
stereosiomers, 2324
structural, 22, 22f
Isotactic polypropene, 23
K
Knotting instruments, 176
L
Labile catalysts, 135
Lactide dimer
to remove water molecule, 37
stereoisomeric structures of, 38f
Laminar gas flow, 195196
Langerhans, for transplantation, 325
Laparoscopic, 176
Laryngeal structures, 196
Laryngoscopy, 210
Laser ablation, 175
Left ventricular assist devices (LVADs),
62
HeartMate II, 158
intermediate-to-chronic, 159160
short-term circulatory support, 161
Left ventricular assist system (LVAS), 160
Left ventricular opacification (LVO), 256
Linear low-density polyethylene
(LLDPE), 13, 34
Lipopolysaccharide (LPS), 7980
Liquid crystalline polymer, 37
Liquid silicone rubber (LSR), 13,
139140
Low-density polyethylene (LDPE), 34
Lung
cystic fibrosis (CF), 79
isolation, endobronchial blocking
devices, 199f
Lysine diisocyanate, 62
M
Magnetic resonance imaging (MRI)
machines, 21
Magnetic vascular positioner (MVP), 177
Mallampati score, 200201
Material suppliers, regulations
applicability of, 345
Medical devices—material selection
process
chemical resistance, 31
common medical device polymers,
3449
electrical properties, 31
FDA device class, 29t
joining and welding, 33
leachables and extractables, 3233
long-term durability, 3132
medical grade plastics, 33
physical and mechanical properties,
2930
shelf life and aging, 33
steam sterilization, effect of, 31f
sterilization capability, 31
supplemental tests, 33
thermal properties, 31
USP classification, 30t
Medical devices, USP classification of,
30t
Medical plastic
in common use, 4t
development, timeline of, 2f
device industry overview, 910
historical example, 45
plastics application, 9
Medical robotic systems, 178179
Medium density polyethylene (MDPE), 34
Medium vessels, sutureless anastomoses,
114
Medos-HIA VAD, 158
Medtronic intact, 170
Metered-dose inhalers (MDIs), 218
Methacrylate-based adhesives, use of,
111
Methacrylic acid (MA), 121122
10-Methacryloyloxydecyl
dihydrogenphosphate (10-MDP),
123124
11-Methacryloyloxy-1, 10-
undecanedicarboxylic acid
(MAC-10)
monomers, 124
4-Methacryloyloxyethyl trimellitic acid
(4-MET), 123
350 INDEXMethicillin-resistant S. epidermidis
(MRSE), 82
Methicillin-resistant Staphylococcus
aureus (MRSA), 1819, 82,
8485
Methyl ester (methyl-2-cyanoacrylate),
105106
Methyl/ethyl cyanoacrylate adhesive,
bond strength of, 108t
Methyl methacrylate (MMA), 111,
122123
Microbial colonization control,
biomaterials, 9192
Microbubble applications, in biomedicine
biofilm destruction, 266, 266f
canine heart, ultrasound image of, 260f
components, 254f
compression and rarefaction, 258f
current clinical uses of, 259260
developmental history of, 253
emerging applications, 266268
Food and Drug Administration (FDA),
256257
in gene delivery, 264266
as drug carriers, 264266
gene delivery/drug, 262264
identification/quantification, 262
left ventricular opacification (LVO),
256
lymphosonography, 267268
magnetic resonance imaging, 267
microbubble-specific ultrasound modes,
259260
nanobubbles, 267
noninvasive pressure estimation,
266267
overview of, 253257
preparations table, 257t
structure/function/use, table of, 255t
targeting, 260262
active, 262
atherosclerosis, 262f
biotinlylated microbubble, 261f
ligand/receptor, 261262
timeline, 254f
tissue engineering, 267
ultrasound contrast agent Targestar-B,
frequency response of, 258f
ultrasound imaging, interactions of,
257259
Microbubble cavitation, 263
Microbubble-assisted drug, gene delivery,
262264
Microbubble-based ultrasound contrast
applications, 260
Micromolding, 16
Microwave ablation, 175
Mild tissue reaction, 114
Minimally invasive cardiology tools,
171174
Minimally invasive surgery (MIS), 151,
175185
CardioVations, 176
classical thoracoscopic tools, 176177
Coalescent Surgical, 176
coronary surgery, anastomotic devices
for, 176
laparoscopic suturing, 176
Passport, 176
robot daVinci, 180f
robots replacing, 178
Spyder device, 177
surgical robots, 177182
symmetry bypass system aortic
connector, 176
Minimally invasive valve implantation,
185186
Ministry of Health, Labor, and Welfare
(MHLW), 343
Mitral valve area (MVA), 162
Mitral valve, physical percutaneous balloon
valvuloplasty simulation, 173f
Mitral valve replacement (MVR), 167
heterograft tissue valves, 167
with mechanical prostheses vs.
bioprostheses, 170171
Mitral valvuloplasty, hemodynamic
improvement, 173
Monocyte, 293294
Motion preservation spine technology,
232233
Multi-locus strain typing (MLST), 80
Murphy eye, 192
Myocardial infarction (MI), 151
N
Natural antibiofilm strategies, 91
Natural orifice transluminal endoscopic
surgery (NOTES), 11
Natural polymers, 6162
Neoplasia, targeting, 261262
Nerve guidance, 68
Neuragen nerve guide, 292
Neural stem cells, proliferation of, 290
New animal drug applications (NADA),
340
Nexaband liquid, 113
Non-woven electrospun fibers, 284
Nucleic acid-based detection methods,
8485
N-vinyl-2-pyrrolidone (NVP), 56
O
Octylcyanoacrylate, 108109
Octyl-2-cyanoacrylate (2-OCA), 108
Off-pump coronary artery bypass
(OPCAB)
anastomotic devices, 177
lateral wall grafting, 177
Oligo(polyethylene glycol) fumarate
(OPF), 291
Organization of Pharmaceutical Safety
and Research (OPSR), 343
Orthopedic implant infections, 8788
Orthopedic implant materials, 93
Orthopedic procedures, 11
Oxygen transmission
hydrophilic monomers, 5658
silicone hydrogel lenses and
conventional hydrogel lenses, 42
P
P. aeruginosa, 8081
Pacemaker, 171
Parkes, Alexander, 3f
Parylene, 47
coatings, 47
polymer molecules, structures of, 47f
PennState LionHeart, 157
Peptic ulcer bleeding, 115
Percutaneous balloon dilation, 173
Percutaneous balloon valvuloplasty, 173
Percutaneous transluminal coronary
angioplasty (PTCA), 172173
Percutaneous valve, 185186
Peripheral nervous system (PNS), 67
Permeant molecule, tortuous path of, 27f
Pharmaceutical Affairs Law (PAL), 343
Pharmaceuticals and Medical Devices
Agency (PMDA), 343
Photo-encapsulation, 286
Photopolymerization, 283
Pill Cam, 14
Pilot balloon repair device, 194f
Pittsburgh-Thermo cardiosystems,
159160
Planktonic bacteria, 7980, 92
Plastic compositions, 2229
additives, 2529
antistats, 29
atactic polypropene, structure, 23f
catalysts, 27
coupling agents, 28
impact modifiers, 2728
isomers, 2224
cis/trans-isomers, 23f
geometric, 2223
structural, 22, 22f
isotactic polypropene, structure, 24f
linear/branched/crosslinked polymers,
22
molecular weight, 24
optical brighteners, 28
pigments/extenders/dyes/mica, 28
plasticizers, 28
polymer blends, 2425
polymer properties, 2224
radiation stabilizers, 28
reinforcing fillers, 2526
INDEX 351Plastic compositions (Continued)
release agents, 26
slip additives/internal lubricants, 2627
stereoisomerism, 23
stereosiomers, 2324
syndiotactic polypropene, structure of,
24f
thermal stabilizers, 28
tougheners, 2728
Plastics, in medical devices
bisphenol A (BPA), 1718
compatibility, 1415
construction, commoditizing materials,
1516
diethyl hexyl phthalate (DEHP)
plasticized PVC, 17
ecological/environmental concerns,
1617
energy costs, 18
functionality, 1314
global influences, 1819
economic pressures, 19
manufacturing, 18
markets, 18
SARS (severe acute respirator
syndrome), 1819
light weighting, 15
market factors affecting, 1719
material costs/process improvements,
15
need for “green,” 18
technology innovations, 16
trends, 1317
Plastics production, timeline of, 2f
Plastics, story, 23
Plastics suppliers
Australia, 343344
CE marking declaration, 342f
China, 343
European Union medical device
directive, 341343
FDA 21 CFR Part 820, 339t
FDA master files, 340
history, 337338
India, 344
ISO 13485, 340343, 341t
Japan, 343
South America, 344
United States regulations, 338340
Plastic-to-rubber bonds, 106
Platelet additives, 26
Pneumatic pulsatile VADs, 160
Pneumatically driven artificial heart
(POLTAH)
artificial heart, schematic diagram of,
154f
design process, 153f
in vivo, 165f
Pneumatically driven ventricular assist
device (POLVAD)
implantation, semiautomatic tools, 153f
Polish ventricle assist devices,
158159
Pneumomediastinum, 219
Pneumoperitoneum, 219
Pneumothorax, 219
Polyamides (nylon), 4t
Poly glycolic acid (PGA), 15, 66, 305,
315316
Poly(amino acids), 321
Polyaryletheretherketone (PEEK), 231232
applications. See Spinal implants,
polyaryletheretherketone (PEEK)
applications
carbon fiber-reinforced (CFR), 233
Polyaryletherketone (PAEK)
all-polymer articulations, 246
biomaterials, 231
Polybutadiene, 25
Polybutylene terephthalate (PBT), 24
Polycaprolactone (PCL) polymers, 15
Polycarbonate (PC), 4t, 24
steam sterilization, effect of, 31f
Polydimethylmethylhydrogenosiloxane,
135
Polydimethylsiloxane (PDMS), 131132,
141
see also Silicone rubber
Poly-p-dioxanone (PDS), 66
Polyester-based TPUs, 45
Polyether ether ketone (PEEK), 4344
applications and uses, 44, 46
EtO resistance, 43, 46
gamma radiation resistance, 43, 46
polymers, 13
rod system, 244f
steam sterilization resistance, 4344
structure of, 43f
Polyether imide (PEI), 13
PEI-DNA complexes, 288289
Polyethersulfone (PES), 41
Polyethylene (PE), 13, 34
polyvinyl chloride (PVC), 22
Poly(ethylene glycol) (PEG), 283
brushes, 255
interpenetrating polymer networks
(IPNs), 60
Polyethylene terephthalate (PETE), 4t, 5,
13, 24, 62
Polyhydroxyalkanoates (PHA), 38,
313314
Poly(2-hydroxyethyl methacrylate)
(PHEMA), 5658
Polyhydroxyhexanoate (PHH), 38
Polyhydroxyvalerate (PHV), 38
Polylactic acid (PLA), 15, 64, 315316
electron beam sterilization, effect of,
32f
lactic acid, conversion of, 37f
microbubbles, 265266
Poly(lactic-co-glycolic acid) (PLGA), 64
Poly-L-lysine, 285286
Polymerase chain reaction (PCR)
detection techniques, 8485
Polymer-shelled microbubbles, 265266
Polymeric biomaterials
applications of, 55
artificial cornea, 5860
in cardiovascular diseases, 6264
expanded PTFE, 6364
polyethylene terephthalate, 63
polyurethanes, 6263
for wound closure, 6466
common monomers, chemical
structures of, 57f
contact lens, 5658
extracorporeal artificial organs, 6667
glyceryl methacrylate (GMA), 5658
intraocular lens, 58
for IOLs, 59t
natural polymers, 6162
for nerve regeneration, 6768
in ophthalmology, 5660
in orthopedics, 6062
polyacrylates, 61
polyethylene, 6061
Polymeric coatings, self-assembled
monolayers (SAMs), 93
Polymers, 323
common medical device
fluoropolymers, 4749
hydrogel (acrylate), 42
polyacrylate (acrylic, PMMA),
4142
polycarbonate, 3840
polyester, 3637
polyethersulfone, 41
polyethylene, 3435
polypropylene, 3536
poly-p-xylylene (Parylene), 47
polystyrene, 36
polysulfone (PSU), 4243
polyvinyl chloride, 4041
schematic of, 44f
sterilization matrix of, 50t
thermoplastic elastomers (TPE,
TPU), 4446
thermoset elastomers—silicone, 46
devices, legacy materials, 1213
molecular weight, 24
natural, 6162
tissue-engineered products, 323325
Poly(methyl methacrylate) (PMMA), 4t,
56, 92
application of, 61
Polynucleotides, gene delivery, 314
Poly(p-dioxanone) (PDS), 318
Polypropylene (PP), 4t, 13
Polysaccharide teichoic acid fibers,
7980
352 INDEXPolysaccharides, 310311
Polysialic acid, 68
Polysiloxanes, structure, 46f
Polystyrene (PS), 13, 25, 36
Polysulfone (PSU), structure of, 43f
Polytetrafluoroethylene (PTFE), 3
chemical structure of, 49f
gamma sterilization, effect of, 32f
Poly(tetramethylene ether) glycol
terephthalate (PTMG), 6566
Poly(tetramethylene ether terephthalate)
copolymers of, 6566
Polyurethane (PU), 4t, 5960
bioresistant, 6263
mechanisms responsible for, 6263
physical percutaneous balloon
valvuloplasty simulation, 173f
Poly(vinyl alcohol) (PVA), 323
homopolymer of, 5960
Polyvinyl chloride (PVC), 5, 192
Polyvinylidene fluoride (PVDF), 65
Positive end-expiratory pressure therapy
(PEEP) therapy, 216
Postanesthesia care unit (PACU),
204205
Posterior capsular opacification (PCO), 58
Posterior lumbar interbody fusion (PLIF),
233234
Premarket approval (PMA), 340
PressureEasy device, 204
Prostate specific antigen (PSA), 12
silicone PSAs, 140141
Proteoglycans (PGs), 309310
Pseudomonas aeruginosa, 110
Pulmonary artery axial blood pump,
185f
Pulmonary artery stenosis, 173
Pulmonary toilet bronchoscopy, 213214
R
Radiation sterilization, 38
Radiofrequency, 174175
Random copolymers, 3536
Rats, implant materials, 9192
Reproductive, 33
Restriction fragment length polymorphism
(RFLP), 8485
Reverse transcriptase PCR (RT-PCR), 83
Rigid gas-permeable (RGP), 56
Risk management, 340
RNAIII-activating protein (RAP), 9192
RNAIII-inhibiting peptide (RIP), 9192
Robotic surgery, 146
Robotic systems, 178179
Robotics, potential applications of,
182
Room temperature vulcanization (RTV),
136137
elastomers, 140
Rubber-to-rubber bonds, 106
S
S. epidermidis, 9293
Safe Medical Device Act (SMDA), 338
Schwann cells, 291292
Self-assembled monolayers (SAMs), 93,
93f
Self-etch adhesives (SEAs), 120121
Severe acute respirator syndrome (SARS),
1819
Short-term circulatory support, 162171
Silicone elastomers, 138139
Silicone gel adhesives, 141
Silicone materials, 131
basic steps, 134t
chemical structure/nomenclature,
131142
development, key milestones, 132t
elastomers, 136140
cross-linking by addition, 137138
cross-linking by condensation,
136137
cross-linking with radicals, 136
filler, 138
processing of, 138140
silica network, 138f
silicone film-in-place, 141
gels, 140
high consistency rubber (HCR), 139
historical milestones, 132
liquid silicone rubber (LSR), 139140
nomenclature, 132133
olymers, preparation, 133
physico-chemical properties, 141142
polycondensation, 133136
polymerization, 133136
silicone adhesives, 140141
bonding adhesives, 140
gel adhesives, 141
pressure-sensitive adhesives, 140
Silicone Shorthand Notation, 133t
Silicone organic copolymers, 141
Silicone polymers, 136
Silicone preparation, catalyst removal, 135
Silicone rubber, 4t, 46
Single use disposables (SUDs), 12
Skin wrinkles, 308
Smooth muscle cells (SMCs), 317318
SonarMed airway monitoring device, 214
Sorin Bicarbon mechanical prosthesis, 170
Spinal cord injuries (SCIs), 292
Spinal implants, polyaryletheretherketone
(PEEK) applications, 232f
autograft-treated goats
histological section of, 239f
cervical/lumbar artificial discs,
244246
CFR-PEEK
and CFR-PEKEKK cages, 235f
lumbar cages, 233237, 234f
transpedicular screw, 240f
early pedicle-based systems, 242243
fused lumbar spinal segment,
radiograph of, 239f
fusion, 237f
radiographic findings, 237f
graf ligaments/dynesys, 242243
inflammatory reaction to CFR-PAEK,
237f
interbody fusion
and cage rage, 233
devices, 232f
motion preservation spine technology,
232233
overview of, 231233
pedicle-based posterior stabilization
rods, 242244, 243f, 244f
PEEK spinal cages, clinical
diagnostic imaging, 236f, 239240
PEEK-on-PEEK lumbar nucleus
replacement (NUBAC), 245f
posterior dynamic stabilization devices,
240244
interspinous process spacers,
241242
spacer, extension-limiting, 241f
spinal fusions, incidence of, 232f
subsidence/wear cages, 240
threaded PEEK
interbody device, 238f
lumbar fusion cages, 237238, 238f
transpedicular screws, 239240
volumetric wear rates, comparison of,
246f
Spyder device, 177
Stainless steel (SS) materials, 1415
Staphylococci, biofilm formation, 8283
Staphylococcus aureus, 110
Staphylococcus epidermidis
adheres, 110, 112
biofilm, 214215, 266
Staphylococcus mucoidy, 81
Starfish2 heart positioner, 177
Starr-Edwards ball valve design, 168
State Food and Drug Administration
(SFDA), 343
Steam sterilization resistance, 37, 41,
4344
Stentless bioprosthetic porcine aortic
valves, 169170
Sterilization methods, 34
with hot air, 39
on parylene, 48t
with peracetic acid, 39
resistance, 35
Subglottic suctioning, 213
Subharmonic-aided pressure estimation
(SHAPE), 266267
Supraglottic airways, 200
Surgery planning
medical applications, 187
INDEX 353Surgery planning (Continued)
remote-control manipulators, 186
RobinHeart robot, 188f
robots, 186
Syncardia systems, 155
Syndiotactic polypropene, 2324
Synthetic polymer, 5
T
Taperguard endotracheal tube cuff, 193f
Thermoplastic polyurethane elastomer,
molecular structure, 45f
Thoracoscopic surgery, 176
Thoratec PVAD (paracorporeal ventricular
assist device), 158
Thrombin, 104
Ti-cron braided polyester suture, 86f
Tissue adhesives
characterize strength, test methods, 110
classification of, 121f
dental applications, 119124
in gastrointestinal endoscopic
procedures, 115116
bleeding from other sources, 115
closure of fistula, 115116
esophageal variceal bleeding, 115
gastric variceal bleeding, 115
peptic ulcer bleeding, 115
hernia incisions, closure of, 116119
open pediatric urological procedures,
114115
plastic surgery, uses, 119
potential cyanoacrylate pitfalls, 118t
in topical skin wounds, 116
wound closure devices, 117t
Tissue valves, 167
Tortuous path effect, 26
Total disc replacements (TDRs), 232233
Total endoscopic coronary artery bypass
(TECAB), 177
Total joint replacement (TJR), 88
Tracheostomy tubes, pressure support, 217
Transfer molding, 139
U
U-CLIP anastomotic device technology,
176177
Ultrahigh molecular weight polyethylene
(UHMWPE) chains, 24
Ultra-low-density polyethylene (ULDPE),
34
Ultrasound ablation, 175
Unfixed biofilms, confocal microscope
images of, 90f
Unique identification (UID), for devices,
14
Urethane bond, 320
Urethanes, 45
Urinary catheters, 7778
V
Valine-proline-glycine-valine-glycine
(VPGVG)
elastin repeat sequences, 310
Valve prostheses, 162171
Valve repair, 164
Valve test tester, 166f
Valve-related problems, 168
bioprosthetic valves, 168
mechanical valves, 168
Valvular heart disease, 151, 162171
VEGFR2-targeted microbubble, 261262
Ventilator-associated pneumonia
(VAP), 193
Ventilator circuits, pressure support, 217
Ventricular assist devices (VADs), 145
implantation, types of, 160161
Vinci S model, 182
Vinci telemanipulator, 181
Vision systems, 16
W
Water uptake adversely influences,
123
Wistar rats, 116118
Wongworawat, 114
WorldHeart, 160
Wound bacterial counts, 113
Woven hydrogel/cell mixtures, 284
Y
Young’s modulus, 316317
Z
Zeus surgical system, 180
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