PEEK Biomaterials Handbook (eBook)

Front Cover 1
Dedication 3
Series page 3
Peek Biomaterials Handbook 4
Copyright 5
Contents 6
Foreword 8
List of Contributors 10
Chapter 1 - An Overview of PEEK Biomaterials 12
1.1 - Introduction 12
1.2 - What Is a Polymer? 13
1.3 - What Is PEEK? 13
1.4 - Crystallinity and PEEK 14
1.5 - Thermal Transitions 14
1.6 - PEEK Composites 15
1.7 - Overview of This Handbook 16
References 17
Chapter 2 - Synthesis and Processing of PEEK for Surgical Implants 20
2.1 - Introduction 20
2.2 - Synthesis of PAEKs 20
2.3 - Nomenclature 23
2.4 - Quality Systems for Medical Grade Resin Production 25
2.5 - Processing of Medical Grade PEEK 26
2.6 - Machining 32
2.7 - Summary 32
Acknowledgments 33
References 33
Chapter 3 - Compounds and Composite Materials 34
3.1 - Introduction 34
3.2 - What Is a Composite Material? 36
3.3 - Additive Geometry, Volume, and Orientation Effects 43
3.4 - Preparation of Materials 47
3.5 - Processing to Make Parts 49
3.6 - Biocompatibility of CFR PEEK 56
3.7 - Summary and Conclusions 57
References 57
Chapter 4 - Morphology and Crystalline Architecture of Polyaryletherketones 60
4.1 - Introduction 60
4.2 - Chain Architecture and Packing 60
4.3 - Crystallization Behavior 63
4.4 - Characterization Techniques 63
4.5 - Structure Processing–Property Relationships 68
4.6 - Summary and Conclusions 69
Acknowledgment 70
References 70
Chapter 5 - Fracture, Fatigue, and Notch Behavior of PEEK 72
5.1 - Introduction 72
5.2 - Fracture and Fatigue of Materials 72
5.3 - PEEK Fracture Studies 75
5.4 - PEEK Notch Studies 76
5.5 - Summary 79
Acknowledgments 82
References 82
Chapter 6 - Chemical and Radiation Stability of PEEK 86
6.1 - Introduction to Chemical Stability 86
6.2 - Water Solubility 86
6.3 - Thermal Stability 87
6.4 - Steam Sterilization of PEEK 87
6.5 - Radiation Stability: Implications for Gamma Sterilization and Postirradiation Aging 87
6.6 - Summary 89
References 89
Chapter 7 - Biocompatibility of Polyaryletheretherketone Polymers 92
7.1 - Introduction 92
7.2 - Cell Culture and Toxicity Studies 93
7.3 - Mutagenesis (Genotoxicity) 95
7.4 - Immunogenesis 95
7.5 - Soft Tissue Response 95
7.6 - Osteocompatibility of PEEK Devices 95
7.7 - Biocompatibility of PEEK Particulate—X-STOP™ PEEK Explant Studies 98
7.8 - Summary and Conclusions 102
References 102
Chapter 8 - Bacterial Interactions with Polyaryletheretherketone 104
8.1 - Introduction 104
8.2 - Bacterial Adhesion to Biomaterials 106
8.3 - The Role of Surface Topography and Chemistry in Bacterial Adhesion 109
8.4 - Strategies to Reduce Bacterial Adhesion to PEEK 114
8.5 - Summary and Perspectives 119
References 120
Chapter 9 - Thermal Plasma Spray Deposition of Titanium and Hydroxyapatite on Polyaryletheretherketone Implants 130
9.1 - Introduction 130
9.2 - Coating Technology 131
9.3 - Biomedical Plasma-Sprayed Coatings 133
9.4 - Coating Analysis Methods 135
9.5 - Substrate Analysis Method 138
9.6 - Plasma-Sprayed Coatings on PEEK-Based Substrates 140
9.7 - Plasma-Sprayed Osteointegrative Surfaces for PEEK: The Eurocoating Experience 142
9.8 - Summary and Conclusions 150
References 150
Chapter 10 - Surface Modification Techniques of Polyetheretherketone, Including Plasma Surface Treatment 156
10.1 - PEEK–Tissue Interactions 156
10.2 - Surface Modification 157
10.3 - Surface Modification Techniques 159
10.4 - Applications of These Surface Modification Methods and the Translation to Industry 162
10.5 - Perspectives 167
References 167
Chapter 11 - Bioactive Polyaryletherketone Composites 174
11.1 - Introduction 174
11.2 - Processing–Structure Relationships 175
11.3 - Structure–Property Relationships 181
11.4 - Concluding Remarks 185
References 185
Chapter 12 - Porosity in Polyaryletheretherketone 192
12.1 - Introduction 192
12.2 - Porous Biomaterials in Existing Implants 193
12.3 - Porous Polymer Production for Industrial Applications 194
12.4 - Manufacturing of Porous PEEK Biomaterials 195
12.5 - Case Study 1—Porosity Through Porogen Leaching at Production Scale 198
12.6 - Case Study 2—Comparison of Small and Large Pore Sizes 203
12.7 - Case Study 3—Mid-Sized Porosity 205
12.8 - Conclusions 207
Acknowledgment 208
References 208
Chapter 13 - Applications of Polyaryletheretherketone in Spinal Implants: Fusion and Motion Preservation 212
13.1 - Introduction 212
13.2 - Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s 213
13.3 - CFR-PEEK Lumbar Cages: The Brantigan Cage 214
13.4 - Threaded PEEK Lumbar Fusion Cages 218
13.5 - Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws 219
13.6 - Subsidence and Wear of PAEK Cages 220
13.7 - Posterior Dynamic Stabilization Devices 221
13.8 - Cervical and Lumbar Artificial Discs 225
13.9 - Summary 226
Acknowledgments 227
References 227
Chapter 14 - Isoelastic Polyaryletheretherketone Implants for Total Joint Replacement 232
14.1 - Introduction 232
14.2 - Incompatible Design Goals for an Uncemented Hip Stem 233
14.3 - Setbacks with Early Polymer–Metal Composite Hip Stems 234
14.4 - The Epoch Hip Stem 235
14.5 - Other PAEK Composite Hip Stems 240
14.6 - Stress Shielding in the Acetabulum 241
14.7 - PEEK in the Acetabulum 243
14.8 - Outlook for PEEK in Orthopedic Implants 246
Acknowledgments 248
References 248
Chapter 15 - Applications of Polyetheretherketone in Trauma, Arthroscopy, and Cranial Defect Repair 254
15.1 - Introduction 254
15.2 - Principles of Fracture Repair 254
15.3 - Principles of Arthroscopic Repair 260
15.4 - Principles of Craniofacial Defect Repair 262
15.5 - Summary 268
Acknowledgments 269
References 269
Chapter 16 - Arthroplasty Bearing Surfaces 272
16.1 - Introduction 272
16.2 - Total Hip and Knee Replacement 272
16.3 - Basic Biotribology Studies of PEEK Articulations 277
16.4 - Hip Resurfacing 280
16.5 - Mobile-Bearing, Unicondylar Knee Joint Replacements 282
16.6 - Other Total Joint Replacement Applications 282
16.7 - MOTIS: Medical Grade CFR-PEEK for Bearing Applications 283
16.8 - Summary and Concluding Remarks 283
Acknowledgments 283
References 283
Chapter 17 - FDA Regulation of Polyaryletheretherketone Implants* 288
17.1 - Introduction 288
17.2 - What Is the FDA? 288
17.3 - Common Misconceptions About What the FDA Does 289
17.4 - Brief History of the FDA 290
17.5 - Medical Device Definition and Classification 292
17.6 - Regulatory Approval Process and Types of Applications 293
17.7 - Content of an FDA Application 295
17.8 - Material Considerations 297
17.9 - Current Uses of PEEK in FDA-Approved Spinal and Orthopedic Implants 298
17.10 - The Use of Master Files in Supplying Material Data for FDA Regulation 299
17.11 - The Use of Standards in FDA Regulation 300
17.12 - Summary and Conclusions 302
References 303
Index 304