Medical Device Materials I I ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Medical Device Materials II Proceedings from the Materials & Processes for Medical Devices Conference 2004 August25-27,2004 St. Paul, Minnesota Edited by Mike Helmus Dana Medlin Sponsored by ASN\ ~ The Materials Information Society ASM International® Materials Park, OH 44073-0002 www .asmintemational.org Medical Device Materials I I ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Copyright© 2005 by ASM International® All rights reserved No part of this book may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the written permission of the copyright owner. First printing, May 2005 Great care is taken in the compilation and production of this Volume, but it should be made clear that NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE GIVEN IN CONNECTION WITH THIS PUBLICATION. Although this information is believed to be accurate by ASM, ASM cannot guarantee that favorable results will be obtained from the use of this publication alone. This publication is intended for use by persons having technical skill, at their sole discretion and risk. Since the conditions of product or material use are outside of ASM's control, ASM assumes no liability or obligation in connection with any use of this information. No claim of any kind, whether as to products or information in this publication, and whether or not based on negligence, shall be greater in amount than the purchase price of this product or publication in respect of which damages are claimed. 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ISBN: 0-87170-824-8 SAN: 204-7586 ASM International® Materials Park, OH 44073-0002 www.asminternational.org Printed in the United States of America Multiple copy reprints of individual articles are available from Technical Department, ASM International. Medical Device Materials I I ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Preface This publication, Materials and Processes for Medical Devices (MPMD), contains papers presented at a conference sponsored by ASM International on August 25-27, 2004 in Saint Paul, Minnesota. In 2002 ASM International organized a Materials for Medical Devices (MMD) Task Force that evaluated the need and feasibility of sponsoring a conference on the topic area of biomaterials. After a year of analysis, organizing, and numerous teleconferences, the first Materials and Processes for Medical Devices Conference was held in Anaheim, California, on September 8-10,2003. The number of technical presentations, exhibitors, and attendees at this conference exceeded the initial estimates and this gave the MMD Task Force an indication of the high level of interest in this technical subject matter. The MPMD Organizing Committee quickly responded by organizing a second conference described in these proceedings. Once again, the number of exhibitors and attendees exceeded the expectations, indicating the intense interest of this topic. The overwhelming success of these two MPMD conferences is attributed to the organizing committee's balance of medical device technology, new materials, new processes, testing issues, regulatory issues, and specific device application concerns. These topical areas are likely to be of interest to material scientists, metallurgical engineers, medical device design engineers, regulatory professionals, government agencies, and medical practitioners involved with the vascular, dental, and orthopedic business segments. By bringing professionals from these diverse backgrounds together in a common forum, the opportunity to transfer new material and process technologies is one of the beneficial outcomes of this conference. Many volunteers from the medical devices industry, suppliers, regulatory agencies, and academia participated by organizing and contributing to the development of this outstanding program. We sincerely thank them for their dedication and commitment. We also thank the staff of ASM International for their assistance in executing the vision and plan of the 2004 MPMD Organizing Committee, as well as the co-sponsors of this event: ASTM F04 Committee, Society for Biomaterials, AAOS, SMST, CRS, and Biomat.net. Mike Helmus Dana Medlin Co-Chair, MPMD Organizing Committee Co-Chair, MPMD Organizing Committee Boston Scientific Corporation Zimmer, Inc. Natick, MA Warsaw, IN 111 Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved CONTENTS Keynote Medical Device Failures – Can We Learn from Our Mistakes?.................................................3 L.E. Eiselstein, B. James, Exponent Failure Analysis Associates, Menlo Park, California Nitinol Fatigue Bending Fatigue Characteristics of Nitinol...................................................................................15 A. Wick, X.Y. Gong, J. Fino, J. Sheriff, A.R. Pelton, Nitinol Devices & Components, Fremont, California High Strain Accelerated Fatigue Failure Testing of NiTi Implantable Devices.........................21 B. Shuman, C. Finger, Spiration Inc., Redmond, Washington K. Perry, Echobio, LLC, Bainbridge Island, Washington Cyclic Properties of Superelastic Nitinol Tubing..........................................................................26 X.Y. Gong, A.R. Pelton, T. Duerig, Nitinol Devices & Components, Fremont, California A. Hall, California Polytechnic State University, San Luis Obispo, California Thermal Processing of Polycrystalline NiTi Shape Memory Alloys............................................32 C. Frick, K. Gall, A. Ortego, J. Tyber, University of Colorado, Boulder, Colorado H.J. Maier, A. EI. M. Maksound, University of Paderborn, Paderborn, Germany Y. Liu, University of Western Australia, Chawly, Australia Hydrogen Effects on Nitinol Fatigue..............................................................................................38 J. Sheriff, A. R. Pelton, Nitinol Devices & Components, Fremont, California L.A. Pruitt, University of California, Berkeley, California Failure Analysis of NiTi Wires Used in Medical Applications....................................................44 B. James, J. Foulds, L. Eiselstein, Exponent Failure Analysis Associates, Menlo Park, California Laser Technologies for Manufacturing Medical Devices Corrosion of Laser Marks on Instruments....................................................................................53 R. Peterson, J. Dickinson, Smith & Nephew, Inc., Memphis, Tennessee Effects of Oxygen Contamination in the Argon Shielding Gas in Laser Welding of Commercially Pure Titanium Thin Sheet.........................................................................59 Y. Zhou, X. Li, University of Waterloo, Waterloo, Ontario, Canada J. Xie, St. Jude Medical Center, Sylmar, California Laser Drilling for Medical Device Manufacturing.......................................................................65 T.L. VanderWert, Prima North America, Champlin, Minnesota iv Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Surface Engineering Pulsed Laser Deposition of Diamondlike Carbon-Hydroxyapatite Composites........................71 R J. Narayan, B.F. Ball, Georgia Institute of Technology, Atlanta, Georgia Metallographic Preparation of Orthopedic Medical Devices......................................................75 G. Lucas, G. Vander Voort, Buehler, Ltd., Lake Bluff, Illinois D. Medlin, Zimmer, Inc., Warsaw, Indiana Structural Properties of PVD Coatings on Implants and their Influence on Stimulation Perfomance in Pacing Applications...................................................................................81 H. Specht, F. Krüger , H. J. Wachter, O. Keitel, C. Leitold, M. Frericks, W. C. Heraeus GmbH & Co. KG, Hanau, Germany Characterization and Comparison of Coated Bone Drill Bits.....................................................85 L. Eschbach, W. Hirsiger, G. Biguin, B. Gasser, Dr. Robert Mathys Foundation, Bettlach, Switzerland The Challenge of Plasma Processing - Its Diversity......................................................................91 M. Larner, S. Kaplan, 4th State, Inc., Belmont, California Mechanical Properties of Calcium Phosphate Invert Glass-Ceramic Coated Ti-29Nb-13Ta-4.6Zr for Biomedical Applications...........................................................97 M. Niinomi, T. Akahori, T. Yamaguchi, Toyohashi University of Technology, Toyohashi, Japan T. Kasuga, Nagoya Institute of Technology, Nagoya, Japan A. Suzuki, Daido Steel Co., Ltd., Nagoya, Japan H. Fukui, Aichi-Gakuin University, Nagoya, Japan Modifying the Mechanical Properties of Porous Equiatomic Nickel-Titanium to Better Mimic Bone..............................................................................................................103 A.P. Jardine, G. Baure, Shape Change Technologies LLC, Thousand Oaks, California Nitinol Properties and Manufacture Device Specific NiTi TTT Diagram: Lessons Learned.................................................................109 B. Shuman, C. Finger, Spiration, Inc., Redmond, Washington K. Perry, Echobio, LLC, Bainbridge Island, Washington Development and Testing of Manufacturable Thin Film TiNi for Medical Devices..................112 A.P. Jardine, G. Baure, A. N. Le, Shape Change Technologies LLC, Thousand Oaks, California G.P. Carman, University of California, Los Angeles, California Clausius-Clapeyron Equations in Different Types of Nickel Titanium Shape Memory Alloy......................................................................................................................116 S. Zhang, M. Denton, S. Fariabi, Edwards LifeSciences, Irvine, California An Investigation of the Effect of Drawing Temperature on Nitinol Processing.........................120 G.F. Archer, Johnson Matthey, San Jose, California Improved Fracture Healing with use of Shape Memory Alloys..................................................124 J. Tyber, J. Toelle, C. Frick, A. Ortega, D. Steinke, E. Hardy, K. Gall, University of Colorado, Boulder, Colorado D. Pacaccio, Inova Fairfax Hospital, Falls Church, Virginia v Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Numerical Modeling Phase Transformations in Nitinol and Challenges for Numerical Modeling.............................131 K.E. Perry, Echobio, LLC, Bainbridge Island, Washington P.E. Labossiere, University of Washington, Seattle, Washington Optimization of a Combined Nitinol/Polymer Device Using FEA...............................................135 E. Konstantino, T. Feld, AngioScore, Inc., Alameda, California S. Keidar, Tel Aviv, Israel G. Gershony, John Muir Medical Center, Walnut Creek, California A Numerical and Experimental Investigation into the Forces Generated when Cutting Biomaterials...........................................................................................................140 C.T. McCarthy, E. O’Dwyer, M. Hussey, M.D. Gilchrist, University College, Dublin, Ireland N.P. O’Dowd, Imperial College, London, United Kingdom Process Simulation Applications in the Medical Industry...........................................................146 D. Lambert, J. Walters, Scientific Forming Technologies Corporation, Columbus, Ohio Nano and Microfabricated Structures Functionally Gradient Diamondlike Carbon Nanocomposites for Medical Applications.........153 R.J. Narayan, D. Scholvin, Georgia Institute of Technology, Atlanta, Georgia Material Design for Neural Applications Using Carbon Nanofibers..........................................159 J.L. McKenzie, R. Shi, T.J. Webster, Purdue University, West Lafayette, Indiana Healthy Aims - Development of Implantable Microsystems Medical Devices...........................165 S.B. Dunkerton, TWI Ltd/Medical Devices Faraday Partnership, Cambridge, United Kingdom D. Hodgins, ETB Ltd., Cedicote, United Kingdom Mechanical and Physical Properties of Medical Devices Fluid Composition Influences Wear Testing of Artificial Knee Implants..................................173 T. Schwenke, M.A. Wimmer, Rush University Medical Center, Chicago, Illinois C. Kaddick, EndoLab GmbH, Rosenheim, Germany The Development of Wear Resistant Titanium-Ceramic Composites for Orthopaedic Implant Devices...................................................................................................................178 S. Abkowitz, S. M. Abkowitz, H. Fisher, P.J. Schwartz, Dynamet Technology, Inc., Burlington, Massachusetts Characterization of Biomedical Wire for Optimum Performance in Suture Needle Manufacture and Use.........................................................................................................184 D. Bradley, S. Chaney, S. Fischer, Fort Wayne Metals Research Products Corporation, Fort Wayne, Indiana The Effect of Bundle Type on Cerclage Cable Fatigue Life.........................................................189 R.W. Jones III, S. Tsai, W. Allen, A. Salehi, Smith & Nephew, Inc., Memphis, Tennessee Effects of Surface Modification of Ti on Cement Bond Strengths..............................................191 P. Agarwal, Y. Oshida, Indiana University School of Dentistry, Indianapolis, Indiana M. Ito, Matsumoto Dental University, Shiojiri, Nagano, Japan vi Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Stainless Steel, Titanium and Cobalt-Base Alloy Developments Development of Beta Titanium Alloys with Low Young's Modulus...........................................197 S. Hanada, T. Ozaki, H. Matsumoto, S. Watanabe, T. Miyazaki, M. Hasegawa, Tohoku University, Sendai, Japan Sandvik Bioline 1RK91 – an Advanced Material for Medical Device Manufacture.................203 S. Cowen, N. Haworth, Sandvik Bioline, Sheffield, United Kingdom J. O. Nilsson, Sandvik Materials Technology, Sandviken, Sweden Optimization of Melt Chemistry and Properties of Drawn Filled Tube (DFT®) Composite Materials of 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy (UNS R30035) Medical Grade Wire with Silver Core..............................................................................209 L. Kay, D. Bradley, Fort Wayne Metals Research Products Corporation, Fort Wayne, Indiana Powder Injection Molding of Titanium Components...................................................................215 K.L. Simmons, E. A. Nyberg, K, S, Weil, Pacific Northwest National Laboratory, Richland, Washington M. Miller, University of Alabama, Birmingham, Alabama Desirable Biocompatible and Physical Characteristics of Selected Stainless Steel Alloys and Specialty Wire Materials for Use in the Design and Manufacture of Implants and Medical Devices...................................................................................................................221 G. Kurisky, R. D’Ambrisi, Maryland Specialty Wire, Cockeysville, Maryland Precision of Fit of the Procera® One-Piece Machined Titanium Implant Framework.............225 R.F. Wang, B.R. Lang, M.E. Razzoog, The University of Michigan, Ann Arbor, Michigan In-Situ Formation of Ti Alloys Via Powder Injection Molding...................................................229 K.L. Simmons, E.A. Nyberg, K. S. Weil, Pacific Northwest National Laboratory, Richland, Washington M. Miller, University of Alabama, Birmingham, Alabama A Study on Low Modulus Titanium Alloys for Biomedical Applications...................................233 S.E. Kim, H. W. Jeong, Y.T. Hyun, Y.T. Lee, Korea Institute of Machinery and Materials, Changwon, South Korea Y.H. Park, J.H. Lee, Dong A University, Busan, South Korea Imaging Quantitative Assessment of Radiofrequency Attenuation Associated With NiTi Stents in Magnetic Resonance Imaging........................................................................................239 E. Walsh, A. Holton, University of Alabama, Birmingham, Alabama R. Venugopalan, Codman and Shurtleff, A J&J Company, Raynham, Massachusetts Tantalum Coated Carbon-Carbon Composite Material for Surgical Implants........................245 S. Eriksen, E. Christensen, B. Gillesberg, L. N. Langmaack, Danfoss Tantalum Technologies, Lyngby, Denmark H. Li, M. Lind, C. Bünger, Aarhus University Hospital, Aarhus, Denmark Radiopaque Marking of Devices for X-Ray Imaging...................................................................251 R. Dickenson, Noble-Met, Ltd., Salem, Virginia vii Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved 3D Imaging and Visualization of Engineering Materials via Medical and Industrial X-Ray Computed Tomography.....................................................................................................257 J. M. Wells, JMW Associates, Mashpee, Massachusetts Three-Dimensional Atomic Structure and Compostitional Analysis of Medical Devices with the Local Electrode Atom Probe...............................................................................263 S.L. Goodman, T. J. Mengelt, M. Ali, S.L.P. Kostrna, R.M. Ulfig, T.F. Kelly, Imago Scientific Instruments Corporation, Madison, Wisconsin A Femoral Canal Sizing Device for Hip Implants.........................................................................267 T. Norman, R. Chasnov, A. Gianettino, A. Julian, M. Michonski, J. Proctor, T. Thompson, S. San Gregory, Cedarville University, Cedarville, Ohio J. D. Blaha, University of Michigan, Ann Arbor, Michigan Managing Post Production Change................................................................................................271 C. Roy, J. Fessler, S. Medhekar, Exponent, Inc., Irvine, California Cardiovascular Device Applications Comparing and Optimizing Co-Cr Tubing Properties for Stent Applications..........................279 P. Poncin, C. Millet, J. Chevry, Minitubes, Grenoble, France J. L. Proft, Metallurgical Solutions, Foster City, California Corrosion of the Nitinol Wire of Endovascular Prostheses: Does Nickel Ion Release Impair the Devices Performance?..................................................................................................284 R. Guidoin, Y. Douville, G. Dionne, Laval University, Quebec City, Quebec, Canada M. King, North Carolina State University, Raleigh, North Carolina A. P. Legrand, ESPCI, Paris, France P. Doppelt, CECM-CNRS, Vitry sur Seine, France Analysis of Nitinol Stents after Long Term in-Vivo Exposure....................................................290 S. Walak, Boston Scientific Corporation, Watertown, Massachusetts A Biomimetic Stent Coating to Reduce Thrombosis and Inflammation.....................................295 J. A. Neff, W. A. Takeguchi, T. Kupumbati, Allvivo, Inc., Lake Forest, California J. Andersson, B. Nilsson, University Hospital, Uppsala, Sweden F. Bexborn, K. Nilsson Ekdahl, University of Kalmar, Kalmar, Sweden Development of Iridium Oxide as a Cardiovascular Stent Coating............................................301 B. O'Brien, Boston Scientific Corporation, Galway, Ireland C. Chandrasekaran, Boston Scientific Corporation, Redmond, Washington Determination of Constricting Forces Required for an Adjustable Systemic to Pulmonary Artery Shunt........................................................................................................................307 N.V. Thuramalla, P. Rachakonda W. I. Douglas, C.F. Knapp, J.K. Knapp, University of Kentucky, Lexington, Kentucky Regulatory and Biocompatibility Issues for Medical Device Manufacturers U.S. FDA Perspective on the Regulations of Cyanoacrylate Polymer Tissue Adhesives in Clincal Applications............................................................................................................315 G. J. Mattamal, U. S. Food and Drug Administration, Rockville, Maryland viii Medical Device Materials II ; P r o c e e d i n g s f o r m t h e M a t e r i a l s & P r o c e s s e s f o r M e d i c a l D e v i c e s C o n f e r e n c e 2 0 0 4 Copyright © 2005 All rights reserved Advanced Manufacturing Technologies Processing of Biocompatible Materials via Metal and Ceramic Injection Molding..................325 J.L. Johnson, D.F. Heaney, The Pennsylvania State University, University Park, Pennsylvania Advanced Electrochemical Finishing Techniques for Medical Device Applications.................331 A. Bonifas, E.J. Taylor, J. Sun, Faraday Technology, Inc., Clayton, Ohio CAD-CAM-Technology for Medical Components........................................................................337 W. Saxler, J. Strohmann, T. Simmich, Alfred H. Schuette GmbH, Cologne, Germany Non-Metallic Biomaterials Mechanical Characterization of a Novel Biodegradable Composite for Use in Osteosynthesis Applications...............................................................................................343 S.D. Ramsay, L. Yang, R.M. Pilliar, J. P. Santerre, University of Toronto, Toronto, Ontario, Canada Advances in Surgical Instrument Technologies Techniques for Investigation of Surgical Cutting Instruments...................................................349 E. Price, G.A. Reilly, B.A.O. McCormack, Institute of Technology, Sligo, Ireland A.C. Macey, Sligo General Hospital, Sligo, Ireland A Durable and Lubricious Polymer Composite Coating for Medical Devices...........................355 J.G. Nawrocki, R. E. Maurer, Ethicon, Inc., a J&J Company, Somerville, New Jersey A Model of the Failure Process of Skin During Cutting...............................................................361 C. Doran, Waterford Institute of Technology, Waterford, Ireland B. McCormack, Institute of Technology, Sligo, Ireland A. Macey, Sligo General Hospital, Sligo, Ireland Corrosion Interpretation of Corrosion Test Results and Prediction of Clinical Performance of Medical Devices...................................................................................................................369 M. Marek, Georgia Institute of Technology, Atlanta, Georgia Passivation Stability of Titanium....................................................................................................375 Y. Oshida, Indiana University School of Dentistry, Indianapolis, Indiana F. Farzin-Nia, ORMCO Corporation, Glendora, California M. Ito, Matsumoto Dental University, Shiojiri, Nagano, Japan W. Panyayong, Prince of Songkla University, Songkhla, Thailand Effect of Grain Size on the Electrochemical Properties of Oxide Films on Titanium and its Alloys For Orthopedic and Spinal Applications.........................................................380 I. Trausch, N. Istephanous, Medtronic Inc., Minneapolis, Minnesota H. Rack, J.I. Qazi, Clemson University, Clemson, South Carolina Effect of Radical Transfer Reaction by Free Oxygen on the Corrosion of Ti-Nb Implant Alloys....................................................................................................................................386 D. Zander, B. Heisterkamp, University of Dortmund, Dortmund, Germany ix