PEEK Biomaterials Handbook

PEEK Biomaterials Handbook

1st Edition - October 28, 2011

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  • Editor: Steven Kurtz
  • Hardcover ISBN: 9781437744637
  • eBook ISBN: 9781437744644

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Description

PEEK 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.

Key Features

  • 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

Readership

Plastics Engineers, Materials Engineers, Biomedical Engineers; Professionals in Spine and Orthopedic Industry and Academia; Teachers and Students of Biomaterials, Medical Device sector OEMs

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

Product details

  • No. of pages: 306
  • Language: English
  • Copyright: © William Andrew 2011
  • Published: October 28, 2011
  • Imprint: William Andrew
  • Hardcover ISBN: 9781437744637
  • eBook ISBN: 9781437744644

About the Editor

Steven Kurtz

Dr. Kurtz has been researching ultra-high molecular weight polyehtylene(UHMWPE) for use in orthopedics for over 10 years. He has published dozens of papers and several book chapters related to UHMWPE used in joint replacement. He has pioneered the development of new test methods for the material in orthopedics. Dr. Kurtz has authored national and international standards for medical upgrade UHMWPE.

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.

Affiliations and Expertise

Director, Implant Research Center and Associate Professor, Drexel University; Research Assistant Professor, Thomas Jefferson University, Philadelphia, PA, USA

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