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PEEK Biomaterials Handbook
- 1st Edition - October 28, 2011
- Editor: Steven M. Kurtz
- Language: English
- Hardback ISBN:9 7 8 - 1 - 4 3 7 7 - 4 4 6 3 - 7
- eBook ISBN:9 7 8 - 1 - 4 3 7 7 - 4 4 6 4 - 4
PEEK biomaterials are currently used in thousands of spinal fusion patients around the world every year. Durability, biocompatibility and excellent resistance to aggressive st… Read more
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Request a sales quotePEEK biomaterials are currently used in thousands of spinal fusion patients around the world every year. Durability, biocompatibility and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and hip replacements to finger joints and dental implants.
This Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design and surgical applications.
Steven Kurtz, author of the well respected UHMWPE Biomaterials Handbook and Director of the Implant Research Center at Drexel University, has developed a one-stop reference covering the processing and blending of PEEK, its properties and biotribology, and the expanding range of medical implants using PEEK: spinal implants, hip and knee replacement, etc.
- Covering materials science, tribology and applications
- Provides a complete reference for specialists in the field of plastics, biomaterials, biomedical engineering and medical device design and surgical applications
Plastics Engineers, Materials Engineers, Biomedical Engineers; Professionals in Spine and Orthopedic Industry and Academia; Teachers and Students of Biomaterials, Medical Device sector OEMs
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
- No. of pages: 306
- Language: English
- Edition: 1
- Published: October 28, 2011
- Imprint: William Andrew
- Hardback ISBN: 9781437744637
- eBook ISBN: 9781437744644
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Steven M. Kurtz
As a principle engineer at Exponent, an international engineering and scientific consulting company, his research on UHMWPE is supported by several major orthopedic manufacturers. He has funding from the National Institutes for Health to stdy UHMWPE changes after implanatation in the body, as well as to develop new computer-based tools to predict the performance of new UHMWPE materials.
Dr. Kurtz is the Director of an orthopedic implant retrieval program in Philadelphia which is affiliated with Drexel University and Thomas Jefferson University. He teaches classes on the performance of orthopedic polymers (including UHMWPE) at Drexel, Temple, and Princeton Universities.