Conference
Tuesday, October 12
| 102: Design of PEEK Implantables |
|
Chair: Steve Kurtz, Ph.D., Corporate Vice President & Director, Philadelphia Office, Exponent
Part I: PEEK Appetizer
Overview of PEEK Biomaterials: Steve Kurtz
Making the Donuts: Grade Selection and Processing: Ken Kostecki, Technical Support Manager, Invibio
- Factors to consider in selecting the proper grade of PEEK material.
- Overview of recommended processing parameters and procedures for Implatable PEEK materials.
Part II: PEEK Design Pioneers
Origin of PEEK Brantigan Spinal Cages: Bill Christianson, Worldwide Vice President, Regulatory Affairs and External Relations, DePuy Spine
- PEKEKK, and later, PEEK reinforced with carbon fiber were tested for biocompatibility as a long term implant.
- All tests indicated that the material is inert, not degraded by two year inplantation in an animal model.
- Test data were sufficient for the FDA to approve the materials as safe for human implantation.
Design and Development of the Epoch Stem: Mike Hawkins, Ph.D., Vice President, Corporate Research, Zimmer, Inc.
Panel Discussion – What are the Regulatory Hurdles for PEEK Implantables?: Jonathan H. Peck, Scientific Reviewer, FDA and faculty
Part III: Designing PEEK Implantables for New Applications
Design of PEEK Orthopedic Bearings: Jim Nevelos, PhD, Director, Hip Research, Stryker Orthopaedics
- Clinical issues with contemporary bearings
- Development and validation of CFR-PEEK bearings in 2 designs
- Lab test data
- Clinical data
Design of Bioactive PEEK Composite Implants: Prof. Ryan K. Roeder, Associate Professor, University of Notre Dame
- Clinical relevance
- History of the design of bioactive polymer composites
- Hydroxyapatite whisker reinforced polymers
- Porous and bioactive PEEK
Metal and HA Coating Technologies for PEEK Implants: Pierfrancesco Robotti, R&D Manager, Eurocoating Spa
- Materials coated: PEEK and CFR PEEK
- Coatings composition: Titanium and/or Hydroxyapatite
- Coatings characterization
- Bulk material characterization
Antimicrobial PEEK Solutions: Dave Jaekel, Drexel University
- Study of bacterial growth and adhesion on PEEK
- Plasma treatment influences
- Alternative surface treatment benefits
- Current research: silver composites and antibiotic tethering
Panel Discussion – What is the future for PEEK Implantables?: SMK Moderator
|
Steve Kurtz, Ph.D., Corporate Vice President & Director, Philadelphia Office, Exponent
Dr. Steven M. Kurtz is a Corporate Vice President and Director of Exponent's Philadelphia, Pennsylvania office. Concurrently, he serves as a part-time Research Professor and director of the Implant Research Center at Drexel University's School of Biomedical Engineering, Science, and Health Systems. Dr. Kurtz' professional career has involved the evaluation of medical device technologies, from a combined analytical, experimental, and clinical perspective. His research activities have emphasized real-world clinical performance of medical devices, including orthopedic, spine, and cardiovascular implants, as assessed by human implant retrieval specimens and national health care databases; mechanical behavior of synthetic biomaterials; contact mechanics of artificial joints; and structural evaluation of bone-implant systems. Dr. Kurtz is active in many professional societies, including the American Academy of Orthopedic Surgeons, the Spine Arthroplasty Society, and the American Society for Testing and Materials. Dr. Kurtz has edited four books and written over 110 journal articles and 300 conference abstracts. He is the founding editor of two educational websites: the UHMWPE Lexicon (www.uhmwpe.org) and the Medical PEEK Lexicon (www.medicalpeek.org). He has recently completed the 2nd Edition of the UHMWPE Biomaterials Handbook.
Overview of PEEK Biomaterials
Information to come.
Steve Kurtz, Ph.D., Corporate Vice President & Director, Philadelphia Office, Exponent
Dr. Steven M. Kurtz is a Corporate Vice President and Director of Exponent's Philadelphia, Pennsylvania office. Concurrently, he serves as a part-time Research Professor and director of the Implant Research Center at Drexel University's School of Biomedical Engineering, Science, and Health Systems. Dr. Kurtz' professional career has involved the evaluation of medical device technologies, from a combined analytical, experimental, and clinical perspective. His research activities have emphasized real-world clinical performance of medical devices, including orthopedic, spine, and cardiovascular implants, as assessed by human implant retrieval specimens and national health care databases; mechanical behavior of synthetic biomaterials; contact mechanics of artificial joints; and structural evaluation of bone-implant systems. Dr. Kurtz is active in many professional societies, including the American Academy of Orthopedic Surgeons, the Spine Arthroplasty Society, and the American Society for Testing and Materials. Dr. Kurtz has edited four books and written over 110 journal articles and 300 conference abstracts. He is the founding editor of two educational websites: the UHMWPE Lexicon (www.uhmwpe.org) and the Medical PEEK Lexicon (www.medicalpeek.org). He has recently completed the 2nd Edition of the UHMWPE Biomaterials Handbook.
Making the Donuts: Grade Selection and Processing
This presentation will cover both grade selection and processing of implantable PEEK materials.
Numerous physcial, mechanical, and processing requirements, as well as application driven properties must be considered in seleting the proper grade of PEEK. This portion of the presentation aims to identify these considerations in order to guide those specifying materials to an informative material decision.
The second part of the presentation provides an overview of key PEEK processing considerations that will help guide those producing implantable PEEK components around common pitfalls, and will aide in successful manufacturing.
Ken Kostecki, Technical Support Manager, Invibio
In his current position, Mr. Kenneth M. Kostecki is responsible for all US Technical Support for Invibio, Inc, makers of PEEK-OPTIMA® and PEEK-CLASSIXT Class XII, and Class VI medical grade materials.
His primary function is to provide technical support to Invibio's customers in the Orthopedic, Spine, Dental, Cardiac, and Neurological Industries. In this role he is tasked with providing design and process troubleshooting support for injection molding, machining, extrusion, compression molding, and other processing methods.
Prior to his position at Invibio, Kenneth held positions at GE/Momentive Silicones where he undertook the role of Field Applications Engineer, and at Sanford/Newell-Rubbermaid where he served as a Materials Engineer for all Sanford product brand lines. Furthermore, at the start of his professional career, he completed the Engineer in Training Program at Phillips Plastics Corporation, which provided him with a knowledge of the properties and processing of a wide array of commodity and engineering grade thermoplastic Resins.
Kenneth holds a degree in Composite Materials Engineering from Winona State University, where he graduated in 2001. Most recently in 2009, he completed his MBA studies and graduated at the top of his class from the University of Wisconsin-Whitewater, with an emphasis in Management.
Origin of PEEK Brantigan Spinal Cages
The Brantigan Lumbar I/F Cage was the first implantable orthopedic device approved by the FDA for human use. The preclinical biocompatibility and bench testing will be described and a brief overview of the IDE clinical data that led to the PMA approval will be presented.
Bill Christianson, Worldwide Vice President, Regulatory Affairs and External Relations, DePuy Spine
Bill started his career in Spine joining AcroMed in June 1990. He held positions of increasing responsibility in regulatory affairs, clinical affairs, and quality assurance. After AcroMed's acquisition by DePuy in 1998, and DePuy's subsequent acquisition by Johnson & Johnson, Bill contined to oversee regulatory and clinical affairs; later reimbursement, surgeon contracting and external relations came under his purview. Bill holds a Bachelor of Arts degree in human physiology and a Master of Business Administration degree and currently resides in Duxbury, MA.
Design and Development of the Epoch Stem
Information to come.
Mike Hawkins, Ph.D., Vice President, Corporate Research, Zimmer, Inc.
Information to come.
Design of PEEK Orthopedic Bearings
All contemporary orthopaedic bearings have issues with wear, wear debris, noise generation, fracture and so on. PEEK has great promise as a bearing material although the ideal formulation and design has proven elusive.
Jim Nevelos, PhD, Director, Hip Research, Stryker Orthopaedics
Following a degree in Materials Science and Engineering and a Masters in Tribology, Jim went on to complete his PhD on the Tribology of Ceramic on Ceramic Hip Joints. As part of this work there were publications on the phenomenon of Stripe Wear and the first reproduction of this in the laboratory using Micro-separation conditions. Jim has held Product Management positions at Corin and Zimmer working with hip resurfacing in particular before joining Stryker Europe to manage their conservative hip and tribology programs for Europe. Currently the Director of Hip Research at Stryker Orthopaedics in the USA, Jim has also published on the design and wear of dual mobility articulations, metal on metal hips, surface engineering and uni-compartmental knees.
Design of Bioactive PEEK Composite Implants
The addition of calcium phosphates (such as hydroxyapatite, beta-tricalcium phosphate, etc.) to bioinert polymers (such as polyethylene and polyarylethereketones) offers a robust system to engineer implant biomaterials with tailored mechanical, biological and surgical function. The historical design rationale has been to reinforce a tough, biocompatible polymer matrix with a rigid, bioactive filler. The effects of the polymer composition and molecular orientation; the reinforcement/polymer interface; and the reinforcement content, morphology, preferred orientation and size will be reviewed with respect to mechanical properties, drawing frequent comparisons between various bioactive composites and bone tissue. Recent investigations in the design of hydroxyapatite (HA) whisker reinforced polyaryletherketone biocomposites will be highlighted. Novel powder processing and compression molding methods enabled the dispersion of high volume fractions of HA reinforcements and the addition of a tailored porosity. Single crystal HA whiskers enabled improved load-transfer from the matrix to reinforcement, resulting in significantly improved static and fatigue properties when directly compared to equiaxed powder reinforcements, and often mimicking the elastic properties cortical and trabecular bone.
Prof. Ryan K. Roeder, Associate Professor, University of Notre Dame
Ryan K. Roeder has B.S. and Ph.D. degrees in Materials Engineering from Purdue University in 1994 and 1999, respectively. After Purdue, Ryan completed a two year post-doctoral research appointment in the Department of Orthopaedic Surgery at the Indiana University Medical Center. Ryan has been a faculty member in the Department of Aerospace and Mechanical Engineering and Bioengineering Graduate Program at the University of Notre Dame since 2001. He teaches courses on biomaterials, failure of materials, mechanical behavior of materials, manufacturing processes for materials and solid mechanics. His research activities have been supported by the National Institutes of Health, the U.S. Army Peer-Reviewed Medical Research Program, the National Science Foundation, the Centers for Disease Control and Prevention, the Indiana 21st Century Fund, and private corporations. He has published over 40 papers in peer-reviewed journals and 3 patents.
Metal and HA Coating Technologies for PEEK Implants
The use of PEEK and Carbon Fiber-Reinforced PEEK (CFR-PEEK) is notably increasing in the biomedical field, especially in spine applications, due to its biocompatibility, radiolucency and favourable stiffness values. In order to improve the bone-implant interface, PEEK implants may be coated with Titanium (Ti) or Hydroxyapatite (HA) via Plasma Spray (PS) processes.
Coatings characterization was performed by SEM analyses, profilometry and optical image analyses. Basic data as bulk surface covering capability, coating porosity, coating roughness and thickness were collected along with adhesion strength coating-substrate.
Parallel with coating characterization it was performed a chemical, physical and mechanical investigation onto coated PEEK samples. This part of the work aims to detect if Plasma Spray (PS) coating process affects the hosting PEEK polymer. Moreover extended fatigue tests screened some potential successful applications from risky bulk-coating-device associations.
A properly designed and applied plasma spray process is able to coat PEEK or CFR-PEEK components with potentially improved bone apposition without damaging the substrate’s properties and the coating reliability.
Pierfrancesco Robotti, R&D Manager, Eurocoating Spa
Pierfrancesco Robotti had his MSc in Biomedical Engineering C/o Milan Polytechnic University, Italy. He has served for about 8 years C/o Tecres spa - Italy, an international market leader company, manufacturer of acrylic based bone cements world wide. He was initially a Researcher, later on Research Officer and finally he had Officer responsibility to coordinate Regulatory Affair activities.
Since 2005, he is Research Officer C/o Eurocoating SPA - Italy, an international market leader company, manufacturer of porous structures for bone integration world wide. Eurocoating spa among the others activities, has in place coating services to enable uncemented prostheses fixation to bone. Specifically Eurocoating has developed processes to enable direct bone apposition onto PEEK and CFR-PEEK components by coating the polymer with either Titanium or/and Hydroxyapatite. Coating processes were developed to maintain key chemical - physical and mechanical features in the hosting PEEK polymer. PEEK Coating processes are currently exploited for commercial production of orthopaedic and spinal implantable components.
Antimicrobial PEEK Solutions
Polyaryletheretherketone (PEEK) has emerged as the material of choice for spinal fusion instrumentation due to its high strength, biocompatibility, and radiolocuency. However, up to 6.7% of all instrumented fusion surgeries result in infection. These spinal infections have greater morbidity and greater economic burden than its uninfected counterparts. Coupled with PEEK gradually being incorporated into orthopaedic and trauma devices with similar infection profiles, there is a growing interest in the risk of infection on PEEK biomaterials. Recently, studies have emerged focusing on the examination of bacterial adhesion and proliferation on PEEK and methods of biofilm prevention. Research has been conducted into bacterial adhesion profiles on surface topography, and also the influences of oxygen plasma treatment on surface adherence. In addition, within the literature, various coating technologies attempt to put bone attachment at a competitive advantage to bacterial adhesion and promote antibiofouling behavior. Finally, studies are being performed to evaluate active responses to microbial intrusion with both antibacterial silver-PEEK composites and possible antibiotic tethering to PEEK surfaces.
Dave Jaekel, Drexel University
Dave Jaekel received his bachelor's degree in biomedical engineering at Drexel University, and then went on to work as an engineer in the research and development of a spinal nucleus implant. Since then, he has now returned to Drexel to get his Ph.D. in biomedical engineering where his research has focus on crystallinity measurements in PEEK and methods to reduce infection on PEEK implants.
Main Conference Page
