كتاب PEEK Biomaterials Handbook
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 كتاب PEEK Biomaterials Handbook

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PEEK Biomaterials Handbook
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Table of contents
Dedication
Foreword
List of Contributors
Chapter 1. An Overview of PEEK Biomaterials
1.1. Introduction
1.2. What Is a Polymer?
1.3. What Is PEEK?
1.4. Crystallinity and PEEK
1.5. Thermal Transitions
1.6. PEEK Composites
1.7. Overview of This Handbook
Chapter 2. Synthesis and Processing of PEEK for Surgical Implants
2.1. Introduction
2.2. Synthesis of PAEKs
2.3. Nomenclature
2.4. Quality Systems for Medical Grade Resin Production
2.5. Processing of Medical Grade PEEK
2.6. Machining
2.7. Summary
Chapter 3. Compounds and Composite Materials
3.1. Introduction
3.2. What Is a Composite Material?
3.3. Additive Geometry, Volume, and Orientation Effects
3.4. Preparation of Materials
3.5. Processing to Make Parts
3.6. Biocompatibility of CFR PEEK
3.7. Summary and Conclusions
Chapter 4. Morphology and Crystalline Architecture of Polyaryletherketones
4.1. Introduction
4.2. Chain Architecture and Packing
4.3. Crystallization Behavior
4.4. Characterization Techniques
4.5. Structure Processing–Property Relationships
4.6. Summary and Conclusions
Chapter 5. Fracture, Fatigue, and Notch Behavior of PEEK
5.1. Introduction
5.2. Fracture and Fatigue of Materials
5.3. PEEK Fracture Studies
5.4. PEEK Notch Studies
5.5. Summary
Chapter 6. Chemical and Radiation Stability of PEEK
6.1. Introduction to Chemical Stability
6.2. Water Solubility
6.3. Thermal Stability
6.4. Steam Sterilization of PEEK
6.5. Radiation Stability: Implications for Gamma Sterilization and Postirradiation Aging
6.6. Summary
Chapter 7. Biocompatibility of Polyaryletheretherketone Polymers
7.1. Introduction
7.2. Cell Culture and Toxicity Studies
7.3. Mutagenesis (Genotoxicity)
7.4. Immunogenesis
7.5. Soft Tissue Response
7.6. Osteocompatibility of PEEK Devices
7.7. Biocompatibility of PEEK Particulate—X-STOP™ PEEK Explant Studies
7.8. Summary and Conclusions
Chapter 8. Bacterial Interactions with Polyaryletheretherketone
8.1. Introduction
8.2. Bacterial Adhesion to Biomaterials
8.3. The Role of Surface Topography and Chemistry in Bacterial Adhesion
8.4. Strategies to Reduce Bacterial Adhesion to PEEK
8.5. Summary and Perspectives
Chapter 9. Thermal Plasma Spray Deposition of Titanium and Hydroxyapatite on Polyaryletheretherketone Implants
9.1. Introduction
9.2. Coating Technology
9.3. Biomedical Plasma-Sprayed Coatings
9.4. Coating Analysis Methods
9.5. Substrate Analysis Method
9.6. Plasma-Sprayed Coatings on PEEK-Based Substrates
9.7. Plasma-Sprayed Osteointegrative Surfaces for PEEK: The Eurocoating Experience
9.8. Summary and Conclusions
Chapter 10. Surface Modification Techniques of Polyetheretherketone, Including Plasma Surface Treatment
10.1. PEEK–Tissue Interactions
10.2. Surface Modification
10.3. Surface Modification Techniques
10.4. Applications of These Surface Modification Methods and the Translation to Industry
10.5. Perspectives
Chapter 11. Bioactive Polyaryletherketone Composites
11.1. Introduction
11.2. Processing–Structure Relationships
11.3. Structure–Property Relationships
11.4. Concluding Remarks
Chapter 12. Porosity in Polyaryletheretherketone
12.1. Introduction
12.2. Porous Biomaterials in Existing Implants
12.3. Porous Polymer Production for Industrial Applications
12.4. Manufacturing of Porous PEEK Biomaterials
12.5. Case Study 1—Porosity Through Porogen Leaching at Production Scale
12.6. Case Study 2—Comparison of Small and Large Pore Sizes
12.7. Case Study 3—Mid-Sized Porosity
12.8. Conclusions
Chapter 13. Applications of Polyaryletheretherketone in Spinal Implants
13.1. Introduction
13.2. Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s
13.3. CFR-PEEK Lumbar Cages: The Brantigan Cage
13.4. Threaded PEEK Lumbar Fusion Cages
13.5. Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws
13.6. Subsidence and Wear of PAEK Cages
13.7. Posterior Dynamic Stabilization Devices
13.8. Cervical and Lumbar Artificial Discs
13.9. Summary
Chapter 14. Isoelastic Polyaryletheretherketone Implants for Total Joint Replacement
14.1. Introduction
14.2. Incompatible Design Goals for an Uncemented Hip Stem
14.3. Setbacks with Early Polymer–Metal Composite Hip Stems
14.4. The Epoch Hip Stem
14.5. Other PAEK Composite Hip Stems
14.6. Stress Shielding in the Acetabulum
14.7. PEEK in the Acetabulum
14.8. Outlook for PEEK in Orthopedic Implants
Chapter 15. Applications of Polyetheretherketone in Trauma, Arthroscopy, and Cranial Defect Repair
15.1. Introduction
15.2. Principles of Fracture Repair
15.3. Principles of Arthroscopic Repair
15.4. Principles of Craniofacial Defect Repair
15.5. Summary
Chapter 16. Arthroplasty Bearing Surfaces
16.1. Introduction
16.2. Total Hip and Knee Replacement
16.3. Basic Biotribology Studies of PEEK Articulations
16.4. Hip Resurfacing
16.5. Mobile-Bearing, Unicondylar Knee Joint Replacements
16.6. Other Total Joint Replacement Applications
16.7. MOTIS: Medical Grade CFR-PEEK for Bearing Applications
16.8. Summary and Concluding Remarks
Chapter 17. FDA Regulation of Polyaryletheretherketone Implants
17.1. Introduction
17.2. What Is the FDA?
17.3. Common Misconceptions About What the FDA Does
17.4. Brief History of the FDA
17.5. Medical Device Definition and Classification
17.6. Regulatory Approval Process and Types of Applications
17.7. Content of an FDA Application
17.8. Material Considerations
17.9. Current Uses of PEEK in FDA-Approved Spinal and Orthopedic Implants
17.10. The Use of Master Files in Supplying Material Data for FDA Regulation
17.11. The Use of Standards in FDA Regulation
17.12. Summary and Conclusions
Index
Index
A
ABG II total hip system trials, 265e6
Adhesins, 97e8
Adhesion see Bacterial adhesion.
Anchors, PEEK, 251e4
Anterior lumbar interbody fusion
(ALIF), 206
Arthroplasty bearing surfaces:
about the bearing surfaces, 261, 272
finger joint replacement, 271e2
see also Biotribology studies of
PEEK articulations; Hip and
knee replacement;
Hip resurfacing
Arthroscopic repair, 249e51
about arthroscopic repair, 249e50
anchor materials:
historic, 250
PEEK anchors, 251
PEEK interference screws and
fixators, 251
PEEK suture anchors, 251e4
Artificial discs, 24e5
ASTM standard specification for
PEEK, 291
Atmospheric plasma spraying (APS),
122
Atomic force microscopy (AFM)
evaluation, 154
Autoclaving, PEEK, 76
B
Bacterial adhesion, reduction
strategies for PEEK, 103e8
antiadhesive surfaces, 104
antibacterial surfaces, 104e5
antimicrobials, 105
incorporation of antibiotics into
biomaterials, 105e6
vancomycin surfaces, 105
use of silver, 106
use of silver-PEEK composites,
106e8
Bacterial interactions and adhesion to
biomaterials, 93e109
about adhesion and PEEK, 108e9
about bacteria, 95e6
about bacterial interactions, 93
biomaterials and infection, 94e5
host immune response, role of, 103
nonspecific adhesion, 96e7
electrostatic forces, 96e7
Lewis acid-base forces, 96e7
Lifshitz-van der Waals forces,
96e7
specific adhesion, 97e8
adhesins, 97e8
surface chemistry, influence of, 101e3
with bacterial interactions, 101e3
oxygen plasma treatment, 102
protein interactions, 101
wettability, 101e2
topography, influence of, 98e101
about this influence, 98
benefits of smooth surfaces, 99
effects of manufacturing method,
98e9
nanotopographies, 99e101
BAK cage, 203
Barium sulfate X-ray absorber, 30
BHC stem, 224
Bioactive PAEK composites, 163e74
about the composites, 163e4, 174
bioactive reinforcement, 164e8
composite manufacturing, 168e70
cold pressing and pressureless
sintering, 168
compounding and injection
molding, 168
compression molding, 168e9
heat treatment, 170
processing temperatures, 170
quantitative microstructural
characterization, 170
SLS, 169
tailored macroporosity, 169
PAEK and calcium phosphate
combinations, 163e4, 167
PAEK synthesis and structure, 164
processing-structure relationships,
164e70
summary of investigation, 165e6
Bioactive PAEK composites,
properties, 170e4
biological properties, 170e2
calcium phosphate properties, 171
cell attachment with fibroblasts,
171
HA-reinforcement, 171
osteoconductivity and
osteointegration, 171
solubility product, 171
functional properties, 172
mechanical properties, 172e4
evaluation, 172
HA-reinforced PEEK, 172e3
micromechanical models, 173
porous PEKK and PEEK
scaffolds, 174
tension fatigue, 173e4
Biocompatibility of PEEK polymers,
81e91
about biocompatibility, 81e2, 91
cell culture/toxicity studies, 82e3
CFR PEEK polymer, 45e6
immunogenesis, 84
mutagenesis (genotoxicity) studies,
84
osteocompatibility of PEEK devices,
84e7
soft tissue response, 84
see also Explant studies with PEEK
particulate
Biomedical plasma-spray see Thermal
plasma spray deposition
Biotribology studies of PEEK
articulations, 266e9
articulating against ceramic, 267e8
articulating against themselves,
267e8
Austin et al. aggressive loading
evaluations, 268
lubricant issue, 267
pin-on-discs tests, 268e9
pin-on-plate apparatus, 266e7
ring-on-plate tests, 268
rubbing against metallic
counterfaces, 267e8
293Bone adaptation, 221
Bone ongrowth, 130e1
Bradley hip/stem, 23, 230
Brantigan lumbar cage, 203e7
C
Cage rage, 203
Cambridge cup, 232e4, 269
Carbon fiber-reinforced PEEK (CFR
PEEK) polymer, 23e5
biocompatibility, 45e6
and computer tomography (CT),
24e5
continuous CFR PEEK, 34e6, 37e8
lumber cages, 203e7
and MRI, 24
short CFR PEEK, 32e4, 36e7
and X-rays, 24
see also Composite materials
Carbon fibers, 28
manufacture, 28
tensile strength, 29
Carbon-UHMWPE Poly II composites
problems, 262e3
Cell culture/toxicity studies, PEEK,
82e3
Center for Devices and Radiological
Health (CDRH):
and the FDA, 277e8, 284, 290
guidance by, 124, 125e7
Cervical and lumbar artificial discs,
24e5
CFR-PEEK see Carbon fiberreinforced PEEK (CFR
PEEK) polymer
Characterization techniques, PAEK
polymers, 52e7
about the techniques, 52
density gradient, 53
differential scanning calorimetry
(DSC), 56
FTIR spectroscopy, 55
microscopy, 56e7
x-ray diffraction, 53e5
Charpy impact toughness, 62, 64e5
Chemical stability of PEEK, 75
Chemical structure of PEEK, PEK and
PEKK, 2e3
Classification by FDA of medical
devices, 281e2
Coating analysis, 124e9
ASTM requirements, 124e7
Center for Devices and Radiological
Health (CDRH) guidance, 124,
125e7
see also Substrate analysis
Coating technology, 120e2
thermal spray coatings, 120
see also Thermal plasma spray
deposition
Cold plasma surface modification, 150
Composite materials:
about CFR PEEK polymer, 23e5
about compounds and composite
materials, 25e6
about PEEK composites, 4e5
fiber:
carbon fibers, 28, 29
reinforcement principle, 26
role of, 27e8
fiber length effects, 32
fiber/matrix interface, 28e30
strength of, 30
matrix, role of, 26e7
PEEK polymer matrix, 27
naturally occurring, 25
powder additive for image contrast,
30e2
barium sulphate, 30e1
PEEK-OPTIMA mechanical
properties, 31
wire marker alternative, 31
relation between fiber length, volume
fraction and processing, 33
volume fraction issues, 32
see also Bioactive PAEK composites
Composite materials, processing for
parts, 38e45
processing of CFR PEEK:
filament winding, 41e2
hot forming, 42e4
hot pressing and autoclave
molding, 40e1
machining, 44e5
pultrusion, 41
processing of compounds, 38e40
extrusion, 39e40
injection molding, 38e9
Composites of PEEK, 4e5
Compounds, about compounds and
composite materials, 25e6
Compression molding:
Bioactive PAEK composites, 168
of PEEK, 19e20
Computer tomography (CT), and CFR
PEEK, 24e5
Continuous CFR PEEK material, 34e6
definition, 34
ENDOLIGN, 35e6
manufacturing process, 37e8
interleaving, 38
using pre-impregnated fibrous
material, 38
mechanical properties, 34
processing:
filament winding, 41e2
hot forming, 42e4
hot pressing and autoclave
molding, 40e1
pultrusion, 41
Corona surface modification, 149
Craniofacial defect repair, 251e7
about craniofacial defects, 251e2
historical implant materials, 252e6
alloplastic implants, 255
high-density polyethylene
(HDPE), 255
Hydroxyapatite (HA), 255
metallic implants, 256
polymethyl methacrylate
(PMMA), 253e5
PEEK cranial implants:
about the implants, 256
clinical studies, 256e7
current landscape, 257
Crystal unit cells, all PAEK polymers,
50e1
unit cell dimensions, 51
Crystallinity of PEEK, 3
Crystallite morphology, all PAEK
polymers, 51e2
Crystallization behavior, all PAEK
polymers, 52
D
Density gradient characterization, 53
Development history of PEEK, 1
Differential scanning calorimetry
(DSC):
measurements/characterization, 4, 56
with substrate analysis, 129
Direct osteointegration, 119
Dynamic synovial fluid, 147
Dynesys explants/system, 212
E
Electron beam surface modification,
149
Electrophillic routes to synthesis of
PAEK polymers, 9e11
ENDOLIGN, 35e6
Epoch hip stem, 224e30
Epoch I, 225e9
Explant studies with PEEK particulate,
87e91
overal rating, 90e1
retrieval analysis, 87
X-STOP PEEK IPD System, 87
Extrusion compounding, 36e7
Extrusion of PEEK, 18e19, 20, 39e40
barrel capacity and residence time,
40
barrel temperatures, 40
drive motors, 40
screw design, 40
F
Fatigue crack propagation (FCP), 63
see also Fracture and fatigue of
materials
294 INDEXFDA (Food and Drug Administration),
277e92
about the FDA, 277e8, 291e2
Center for Devices and
Radiological Health (CDRH),
277e8, 290
main responsibilities, 277e8
premarket approval, 278
similar organizations in UK,
Australia and Japan, 277
brief history, 279e81
common misconceptions, 278e9
expanding the indications, 278
indications for use, 278
PEEK approval, 278
who tests?, 279
Master Files, 288e9
medical device definition and
classification, 281e2
IBFD (cages) example, 281e2
spinal implants approvals, 202
standards, use by FDA, 289e91
ASTM standard specification for
PEEK, 291
benefits and limitations, 290e1
material specifications, 289
standard test guides, 289
standard test methods, 289
standards development process,
290
FDA, applications material, 284e6
acceptance criteria of manufacturer,
286
efficacy and effectiveness, 285
failure modes, 285
performance specifications, 285
risk analysis, 285
safety, 285
substantial equivalence to existing
devices, 286
Traditional 510(k) submissions, 284
valid scientific evidence requirement,
284
FDA, current PEEK approvals, 287e8
intervertebral body fusion devices
(IBFD), 287e8
spinal fusion rods, 288
vertebral body replacements (VBR),
288
FDA, regulatory approval process,
282e4
CDRH involvement, 284
device listing, 282
establishment registration, 283
exempt devices, 282, 283
Investigation Device Exemption
(IDE), 283
Investigation Review Boards (IRBs),
284
materials used issues, 286e7
biocompatibility, 287
functionality testing, 286e7
predicates, 283
premarket approval applications
(PMAs), 283e4
premarket notification process, 283,
284
review times, 284
substantially equivalent devices, 283
Fiber reinforcement principle, 26
Fibronectin, 145
Filament winding, 41e2
Fillers, effects on structure and
properties, 58
Film and fiber production of PEEK,
20e1
PEEK monofilament production, 21
Finger joint replacement, 271e2
Fixators, PEEK, 251
Flame surface modification, 148e9
Food and Drug Administration see
FDA
Fourier transform infrared
spectroscopy (FT-IR), 128
Fracture and fatigue of materials,
61e4
fatigue crack propagation (FCP), 63
impact testing, 62
notches, 63e4
stress intensity factor K, 61e2
stress life testing, 62e3
Fracture repair, 243e9
about fracture repair, 243e4
Carter’s theory, 245
Gardner et al., stress fields, 245
mechanical stability, 244e6
PEEK for trauma applications, 247e9
about Peek for trauma, 247e8
current landscape for PEEK,
248e9
limitations, 248
as locking devices to bone plates,
249
radiolucent property, 248
primary healing, 244
resorption, 244
secondary healing, 244
semirigid fixation plates, 246e7
choice of materials, 246e7
CRF-PEEK Snake Plate, 247
flexual fatigue and
thermoformability, 247
‘optically amorphous PEEK, 247
stress shielding after healing, 246
Wolff’s Law, 246
Fracture studies, PEEK, 64e6
fractography and fracture
micromechanisms, 65e8
mechanical properties, 64e5
Charpy impact toughness, 64e5
fatigue crack growth (FCG),
64e5
fracture toughness, 64e5
see also Notch studies, PEEK
FTIR spectroscopy characterization,
55
Fusion see Spinal implants with PEEK
G
Gamma sterilization safety, PEEK,
76e7
Genotoxicity (mutagenisis) studies,
PEEK, 84
Graf ligament system, 212
H
High-pressure forming, 43
Hip and knee replacement, 261e6
carbon-UHMWPE Poly II
composites problems, 262e3
CFR-PEEK composites:
ABG II total hip system trials,
265e6
alumina as femoral head material,
265
early evaluations/comparisons,
261e2, 263e4
superior wear performance of
UHMWPE, 266
Wang et al. tribological
investigation, 264
wear debris issues, 265e6
wear performance issues, 264e5
Zirconia withdrawal from market,
265
see also Biotribology studies of
PEEK articulations
Hip resurfacing, 269e71
Cambridge cup, 269
MITCH PCR horseshoe cup, 269e71
Hot forming, 42e4
composite flow molding, 42
high-pressure forming, 43e4
Hot plasma surface modification,
149e50
Human osteoblast (HOB) tests, 154e5
Hydroxyapatite (HA) coatings, 122e3
I
Immunogenesis, 84
Impact testing, 62
Charpy impact test, 62
Injection molding of PEEK, 16e18
crystallinity issues, 18
for fiber reinforced materials, 17
molds for, 16e17
temperatures required, 17e18
Interference screws , PEEK, 251
Interspinous process spacers (ISPs),
210e12
X-STOP systems, 210e11
INDEX 295Intervertebral body fusion devices
(IBFD), FDA PEEK
approval, 287e8
Ion beam surface modification, 149
Isoelastic PEEK implants, 221e38
about isoelastic PEEK implants,
221e38
BHC stem, 224
bone adaptation, 221
Bradley stem, 230
CFR-PEEK in the acetabulum,
233e6
Cambridge cup, 233e6
MITCH Cup-PCR, 233e7
early setbacks, 223e4
Epoch hip stem, 224e30
Epoch I, 225e9
outlook for PEEK, 236e8
Physiologic Stem, 230
requirements for uncemented hip
stems, 222e3
RMI stem, 224
stress shielding in the acetabulum,
230e3
bone loss, 231
Cambridge cup, 232
cementless cups, 231
long-term clinical consequences,
231
periproshetic bone changes, 231
K
Knee joint replacement:
unicondylar mobile-bearing design,
271
see also Hip and knee replacement
L
Laser surface modification, 149
Lumbar and cervical artificial discs,
24e5
M
Machining PEEK, 21
Magnetic resonance imaging (MRI),
and CFR PEEK, 24
Master Files, use by FDA, 288e9
Matrix, role of, 26e7
PEEK polymer matrix, 27
MG PEEK-OPTIMA processing,
15e21
about MG resin quality systems,
14e15
about PEEK material for processing,
15e16
compression molding, 19e20
extrusion, 18e19
film and fiber production, 20e1
injection molding, 16e18
machining, 21
see also PEEK-OPTIMA
biomaterials
Microscopy characterization, 56e7
MITCH PCR horseshoe cup, 234e7,
269e71
Morphology, all PAEK polymers, 50
Motis (pitch-based CFR-PEEK
OPTIMA), 119, 272
Mutagenesis (genotoxicity) studies,
PEEK, 84
N
Notches, 63e4
notch studies, PEEK, 66e71
Von Mises (VM) stress, 67e8
see also Fracture and fatigue of
materials; Fracture studies,
PEEK
NUBAC intradiscal arthroplasty
device, 214e15
Nucleophillic routes to synthesis of
PAEK polymers, 11e12
NUNEC cervical all-PEEK TDR, 215
O
OPTIMA biomaterials see PEEKOPTIMA biomaterials
Osseoconductivity, 190e2
Osteocompatibility of PEEK devices,
84e7
Osteoconductive surfaces, 119e20
Oxygen plasma surface modification,
152e6
atomic force microscopy (AFM)
evaluation, 154
effects of washing, 152e3
human osteoblast (HOB) tests, 154e5
mineralization, 155e6
scanning electro microscopy (SEM)
roughness checks, 154
stability investigations, 153e4
P
PAEK polymers:
about PAEK polymers, 1e2, 58e9
crystal unit cells, 50e1
crystallite morphology, 51e2
crystallization behavior, 52
fillers, effects on structure and
properties, 58
morphology, 50
polymer backbone, 49e50
temperature, effects on structure and
properties, 57e8
thermal transitions, 57
see also Characterization techniques,
PAEK polymers; Synthesis of
PAEK polymers
Pedicle-based posterior stabilization
(PEEK Rods), 211
PEEK (polyaryletheretherketone):
about PEEK, 1, 2e3
available forms, 3
chemical structure, 2e3
composites, 4e5
crystallinity, 3
development history, 1
UHMWPE, 3
see also Composites of PEEK;
Thermal transitions of PEEK
PEEK interference screws and fixators,
251
PEEK rod posterior lumbar fusion
system, 212e14
clinical relevance evaluation, 213e14
creep and degradation benefits, 212
fatigue testing, 212e13
PEEK suture anchors, 251e4
PEEK-OPTIMA biomaterials,
13e14, 16
LT1, LT2, and LT3, 14
for processing, 16
properties, 14
quality systems, 14e15
see also Carbon fiber-reinforced
PEEK (CFR PEEK) polymer;
MG PEEK-OPTIMA
processing
PEKK (Polyetherketoneketone), 2
PEKs (Polyetherketones), 2
Physiologic Stem, 230
Plasma-sprayed osteointegrative
surfaces for PEEK, 131e9
about Eurocoating’s experience, 131
coating characterization, 131e5
hydroxyapatite coating, 132
Spondycoat, 131e2
substrate characterization, 132e9
fatigue investigations, 133e9
thermal properties, 133
UV degradation, 132
Polyaryletheretherketone see PEEK
Polyaryletherketone polymers see
Bioactive PAEK composites
PAEK polymers
Polyetherketoneketone (PEKK), 2
Polyetherketones (PEKs), 2
Polymers, 2
copolymers, 2
definition, 2
homopolymers, 2
linear and branched polymers, 2
Polymethyl methacrylate (PMMA),
253e5
Porogen leaching for porosity see
Porosity in PEEK case
studies
296 INDEXPorosity in PEEK, 181e97
about porosity in PEEK, 181e2,
196e7
applications, medical, 181
manufacture for medical use,
184e7
evaluation issues, 184
heat sintering, 185e6
micromachining, 186
microwave sintering, 186
particulate leaching, 184e5
PEEK textiles, 186e7
selective laser sintering, 186
porous polymers in industry, 183e4
using amorphous sulfonated
PEEK-WC, 184
using chemical blowing agents,
183
using gas-assisted injection
molding, 183
using nitrogen saturation
technology, 184
using Victrex, 183e4
Porosity in PEEK, case studies:
mid-sized porosity, 194e7
compressive strength
implications, 196e7
process method, 194e5
pore sizes comparisons, 192e5
compressive strength
comparisons, 194e5
with trabecular bone porosity,
192e3
porogen leaching, 187e92
about the study on PEEKOPTIMA, 187e8, 190e2
bone ongrowth quantification,
189
cortical sites, 189
histology, 189e90
mechanical testing, 188
osseoconductivity, 190e2
pore size issues, 191e2
in vitro testing, 188e9
in vivo study, 189
Porous biomaterials in existing
implants, 182e3
in craniomaxillofacial (CMF)
applications, 182e3
limitations, 183
in spinal and orthopedic applications,
182
Posterior dynamic stabilization
devices, 210e14
about the devices, 210
Dynesys explants/system, 212
Graf ligament system, 212
interspinous process spacers (ISPs),
210e12
pedicle-based posterior stabilization
(PEEK Rods), 211
PEEK rods, 212e14
Primary fracture healing, 244
Pultrusion, 41
Q
Quality systems for PEEKOPTIMA, 14e15
Quantitative microstructural
characterization, 170
R
Radiation stability, PEEK, 76e8
gamma sterilization safety, 76e7
postirradiation aging, 78
Resorption in fracture repair, 244
RMI stem, 224
S
Scanning electro microscopy (SEM)
roughness checks, 154
Screws and fixators:
PEEK extrusion, 40
PEEK interference for arthroscopic
repair, 251
transpedicular, 208e9
Secondary fracture healing, 244
Short CFR PEEK material, 32e4
extrusion compounding, 36e7
manufacturing process, 33
mechanical properties, 33e4
Shrouded plasma spray (SPS), 122
Soft tissue response, to PEEK, 84
Solubility product, 171
Spinal fusion rods, FDA PEEK
approvals, 288
Spinal implants with PEEK, 201e16
about spinal implants and fusion,
201e2, 215e16
BAK cage, 203
cage rage, 203
cervical and lumbar artificial discs,
214e15
NUBAC device, 214e15
NUNEC cervical all-PEEK TDR,
215
CFR-PEEK lumber cages, 203e7
anterior lumbar interbody fusion
(ALIF), 206
Brantigan cage, 203e7
fusion results, 205e6
testing and evaluation, 204e5
clinical diagnostic imaging, 208e9
CRF-PAEK, PEEK and PEKEKK
tests/evaluations, 204e6
Food and Drug Administration
(FDA) approval, 202
interbody fusion, history, 202e3
subsidence and wear of PAEK/PEEK
cages, 209e10
threaded PEEK lumbar fusion cages,
207e8
total disc replacements (TDRs), 202
transpedicular fixing/screws, 208e9
see also Posterior dynamic
stabilization devices
Spondycoat, 131e2
Sputter coating surface modification,
149
Stability of PEEK, 75e8
chemical stability, 75
radiation stability, 76e8
with steam sterilization, 76
thermal stability, 76
water solubility, 75
Standards, use by FDA regulation,
289e91
Steam sterilization, PEEK, 76
Stress intensity factor K, 612
Stress life testing, 62e3
Stress shielding:
about stress shielding, 221
in the acetabulum, 230e3
after fracture healing, 246
Substrate analysis, 127e9
differential scanning calorimetry
(DSC), 129
Fourier transform infrared
spectroscopy (FT-IR), 128
test specimens, 127e8
x-ray photoelectron spectroscopy
(XPS), 128
Surface energy and PEEK, 145e6
Surface modification of PEEK,
145e56
biological criteria, 147e8
dynamic synovial fluid, 147
fibroblasts, 148
inflammation process, 147
chemical criteria, 148
chain length, 148
surface orientation, 148
thickness, 148
PEEK surface structure and
chemistry, 146e7
PEEK-tissue interactions, 145e6
fibronectin, 145
surface energy and PEEK, 145e6
water-protein activity, 145
surface analytical assessment, 148
Surface modification of PEEK
techniques, 148e51
application issues, 151e2
chemical:
surface etching, 151
surface grafting, 151
direct physical/chemical, 148e51
INDEX 297Surface modification of PEEK
techniques (Continued)
cold plasma, 150
corona, 149
electron beam, 149
flame, 148e9
hot plasma, 149e50
ion beams, 149
laser, 149
sputter coating, 149
UV/ozone, 150e1
oxygen plasma surface modification,
152e6
Synthesis of PAEK polymers, 9e12
electrophillic routes, 9e11
nomenclature, 12e14
summary of PAEK materials used
for implants, 13
nucleophillic routes, 11e12
OPTIMA PEEK biomaterials, 13e14
VESTAKEEP implantable grade
PEEK, 14
Victrex PEEK (ICI), 13
Zeniva implantable grade PEEK, 14
T
Temperature effects on structure and
properties of PAEK/PEEK,
57e8
Thermal plasma spray deposition,
119e39
about the devices/technology, 120e2
atmospheric plasma spraying (APS),
122
biomedical plasma-sprayed coatings,
122e4
hydroxyapatite (HA) coatings,
122e3
Ti-HA coatings, 123e4
titanium (Ti) coatings, 122
coatings on PEEK-based substrates,
129e31
about the coatings, 129
adhesion strength improvements,
130
bone ongrowth, 130e1
HA coating with APS, 130
UV irradiation issues, 130
plasma spray devices/technology,
120e2
plasma spray parameters, 121e2
shrouded plasma spray (SPS), 122
vacuum plasma spraying (VPS), 122
see also Coating analysis
Thermal stability, PEEK, 76
Thermal transitions of PEEK, 3e4, 57
about transitions for PAEK and
PEEK, 57
DSC measurements, 4
flow temperature, 3e4
glass transition temperature, 3e4
melt temperature, 3e4
Threaded PEEK lumbar fusion cages,
207e8
Ti-HA coatings, 123e4
Titanium coatings, 122
Total disc replacements (TDRs), 202,
215
Total joint replacement see Isoelastic
PEEK implants
Toxicity/cell culture studies, PEEK,
82e3
Transpedicular fixing/screws, 208e9
U
UHMWPE (ultra-high-molecularweight polythene), 3
carbon filled, problems with, 29e30
for hip and knee replacement, 262e3,
266
Unicondylar knee joint replacement,
271
UV irradiation with Plasma coatings,
130
UV/ozone surface modification,
150e1
V
Vacuum plasma spraying (VPS), 122
Vancomycin-tethered surfaces, 105
Vertebral body replacements (VBR),
FDA PEEK approval, 288
VESTAKEEP implantable grade
PEEK, 14
Victrex PEEK (ICI), 13
Von Mises (VM) stress, 67e8
W
Water solubility, PEEK, 75
Wolff’s Law on fracture repair, 246
X
X-ray diffraction characterization,
53e5
small-angle x-ray (SAXS), 55
wide-angle x-ray (WAXS), 53e5
X-ray photoelectron spectroscopy
(XPS), 128
X-rays, and CFR PEEK, 24
X-STOP:
ISPs, 210e11
PEEK IPD System, 87
Z
Zeniva implantable grade PEEK, 14
Zirconia, withdrawal from market


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