Biomedical Engineering Wong Bronzino Peterson BIOMATERIALS B PRINCIPLES AND PRACTICES I BIOMATERIALS O M Most current applications of biomaterials involve structural functions, even in A those organs and systems that are not primarily structural in their nature, or PRINCIPLES AND PRACTICES very simple chemical or electrical functions. Complex chemical functions, such T as those of the liver, and complex electrical or electrochemical functions, such E as those of the brain and sense organs, cannot be carried out by biomaterials R at this time. With these basic concepts in mind, Biomaterials: Principles and I Practices focuses on biomaterials consisting of metallic, ceramic, polymeric, and A composite materials. It highlights the impact of recent advances in the area of nano- and microtechnology on biomaterial design. L S • Discusses the biocompatibility of metallic implants and corrosion in an in vivo environment P • Provides a general overview of the relatively bioinert, bioactive or R surface-reactive ceramics, and biodegradable or resorbable bioceramics I • Reviews the basic chemical and physical properties of synthetic N C polymers, the sterilization of polymeric biomaterials, the importance of I surface treatments for improving biocompatibility, and the application of P chemogradient surfaces for the study of cell-to-polymer interactions L E • Covers the fundamentals of composite materials and their applications in S biomaterials A • Highlights commercially significant and successful biomedical N biodegradable polymers D • Examines failure modes of different types of implants based on material, P location, and function in the body R A The book discusses the role of biomaterials as governed by the interaction C between the material and the body, specifically, the effect of the body environment T on the material and the effect of the material on the body. I C E Edited by S Joyce Y. Wong Joseph D. Bronzino K13339 ISBN: 978-1-4398-7251-2 90000 Donald R. Peterson 9 781439 872512 K13339_Cover_final.indd 1 11/1/12 2:27 PM BIOMATERIALS PRIncIPLES And PRAcTIcES BIOMATERIALS PRIncIPLES And PRAcTIcES Edited by Joyce Y. Wong Joseph d. Bronzino donald R. Peterson CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2013 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20120823 International Standard Book Number-13: 978-1-4398-7419-6 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. 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Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents Introduction ..................................................................................................................................vii Editors ............................................................................................................................................xv Contributors ...............................................................................................................................xvii 1 Metallic Biomaterials ...................................................................................................1-1 Joon B. Park and Young Kon Kim 2 Ceramic Biomaterials ..................................................................................................2-1 W.G. Billotte 3 Polymeric Biomaterials ...............................................................................................3-1 Hai Bang Lee, Gilson Khang, and Jin Ho Lee 4 Composite Biomaterials ..............................................................................................4-1 Roderic S. Lakes 5 Biodegradable Polymeric Biomaterials: An Updated Overview ......................5-1 C.C. Chu 6 Biologic Biomaterials: Tissue-Derived Biomaterials (Collagen) .....................6-1 Shu-Tung Li 7 Biologic Biomaterials: Silk ..........................................................................................7-1 Biman Mandal and David L. Kaplan 8 Biofunctional Hydrogels ............................................................................................8-1 Melissa K. McHale and Jennifer L. West 9 Soft Tissue Replacements ...........................................................................................9-1 K.B. Chandran, K.J.L. Burg, and S.W. Shalaby 10 Hard Tissue Replacements .......................................................................................10-1 Sang-Hyun Park, Adolfo Llinás, and Vijay K. Goel v Introduction I.1 A Brief Note Regarding This Edition This book has updated chapters from a previous edition and some new chapters added. The content remains the same, and the following introduction is taken from the previous edition, with minor changes describing the content of this book. In addition, a number of relevant biomaterials journals have been added to the list. Biomaterials are employed to manufacture devices to replace a part or a function of the body in a safe, reliable, economic, and physiologically acceptable manner (Hench and Erthridge, 1982). A variety of devices and materials are used in the treatment of disease or injury. Common examples include sutures, needles, catheters, plates, tooth fillings, and so on. Biomaterials are synthetic materials used to replace part of a living system or to function in intimate contact with living tissue. The Clemson University Advisory Board for Biomaterials has formally defined a biomaterial to be “a systemically and pharmacologically inert substance designed for implantation within or incorporation with living systems.” Black (1992) defined biomaterials as “nonviable materials used in a medical device, intended to interact with biological systems.” Others include “materials of synthetic as well as of natural origin in contact with tissue, blood, and biological fluids, and intended for use for prosthetic, diagnostic, therapeutic, and storage applications without adversely affecting the living organism and its components” (Bruck, 1980). Another definition of biomaterials is stated as “any substance (other than drugs) or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats, augments, or replaces any tissue, organ, or function of the body” (Williams, 1987) and adds to the many ways of looking at the same but expressing it in different ways. In contrast, a biological material is a material, such as skin or artery, produced by a biological system. Artificial materials that simply are in contact with the skin, such as hearing aids and wearable artificial limbs, are not included in our definition of biomaterials since the skin acts as a barrier to the external world. According to these definitions, one must have a vast knowledge or collaborate with different special- ties in order to develop and use biomaterials in medicine and dentistry as Table I.1 indicates. The uses of biomaterials, as indicated in Table I.2, include replacement of a body part which has lost its function due to disease or trauma, to assist in healing, to improve function, and to correct abnormalities. The role of biomaterials has been influenced considerably by advances in many areas of biotechnology and science. For example, with the advent of antibiotics, infectious disease is less of a threat than in earlier days so that degenerative disease assumes a greater importance. Moreover, advances in surgical techniques and instruments have permitted materials to be used in ways which were not possible previously. This book is intended to breed familiarity in the reader with the uses of materials in medicine and dentistry and with some rational basis for these applications. vii viii Introduction TABLE I.1 Fields of Knowledge to Develop Biomaterials Discipline Examples Science and engineering Materials sciences: structure–property relationship of synthetic and biological materials including metals, ceramics, polymers, composites, tissues (blood and connective tissues), etc. Biology and physiology Cell and molecular biology, anatomy, animal and human physiology, histopathology, experimental surgery, immunology, etc. Clinical sciences All the clinical specialties: dentistry, maxillofacial, neurosurgery, obstetrics and gynecology, ophthalmology, orthopedics, otolaryngology, plastic and reconstructive surgery, thoracic and cardiovascular surgery, veterinary medicine, surgery, etc. Source: Modified from von Recum, A.F. 1994. Annual Biomaterials Society Meeting. Boston, MA: Biomaterials Society. TABLE I.2 Uses of Biomaterials Problem Area Examples Replacement of diseased or damaged part Artificial hip joint, kidney dialysis machine Assist in healing Sutures, bone plates, and screws Improve function Cardiac pacemaker, intraocular lens Correct functional abnormality Cardiac pacemaker Correct cosmetic problem Augmentation mammoplasty, chin augmentation Aid to diagnosis Probes and catheters Aid to treatment Catheters, drains The performance of materials in the body can be classified in many ways. First, biomaterials may be considered from the point of view of the problem area which is to be solved, as shown in Table I.2. Second, we may consider the body on a tissue level, an organ level (Table I.3), or a system level (Table I.4). Third, we may consider the classification of materials as polymers, metals, ceramics, and composites, as shown in Table I.5. In this, the role of such materials as biomaterials is governed by the interaction between the material and the body, specifically, the effect of the body environment on the material and the effect of the material on body (Williams and Roaf, 1973; Bruck, 1980; Hench and Erthridge, 1982; von Recum, 1986; Black, 1992; Park and Lakes, 1992; Greco, 1994). It should be evident from these perspectives that most current applications of biomaterials involve structural functions, even in those organs and systems which are not primarily structural in their nature, or very simple chemical or electrical functions. Complex chemical functions such as those of the liver and complex electrical or electrochemical functions such as those of the brain and sense organs cannot be carried out by biomaterials at this time. TABLE I.3 Biomaterials in Organs Organ Examples Heart Cardiac pacemaker, artificial heart valve, total artificial heart Lung Oxygenator machine Eye Contact lens, intraocular lens Ear Artificial stapes, cochlea implant Bone Bone plate, intramedullary rod Kidney Kidney dialysis machine Bladder Catheter and stent Introduction ix TABLE I.4 Biomaterials in Body Systems System Examples Skeletal Bone plate, total joint replacements Muscular Sutures, muscle stimulator Circulatory Artificial heart valves, blood vessels Respiratory Oxygenator machine Integumentary Sutures, burn dressings, artificial skin Urinary Catheters, stent, kidney dialysis machine Nervous Hydrocephalus drain, cardiac pacemaker, nerve stimulator Endocrine Microencapsulated pancreatic islet cells Reproductive Augmentation mammoplasty, other cosmetic replacements TABLE I.5 Materials for Use in the Body Materials Advantages Disadvantages Examples Polymers (nylon, silicone Resilient Not strong Sutures, blood vessels, hip socket, rubber, polyester, Easy to fabricate Deforms with time ear, nose, other soft tissues, sutures polytetrafluoroethylene, etc.) May degrade Metals (Ti and its alloys, Co–Cr alloys, Strong, tough, May corrode Joint replacements, bone plates and stainless steels, Au, Ag, Pt, etc.) ductile Dense screws, dental root implants, pacer Difficult to make and suture wires Ceramics (aluminum oxide, calcium Very biocompatible, Brittle Dental, femoral head of hip phosphates including inert, strong in Not resilient replacement, coating of dental hydroxyapatite, carbon) compression Difficult to make and orthopedic implants Composites (carbon–carbon, wire, or Strong, tailor-made Difficult to make Joint implants, heart valves fiber-reinforced bone cement) I.2 Historical Background The use of biomaterials did not become practical until the advent of an aseptic surgical technique developed by Dr. J. Lister in the 1860s. Earlier, surgical procedures, whether they involved biomaterials or not, were generally unsuccessful as a result of infection. Problems of infection tend to be exacerbated in the presence of biomaterials, since the implant can provide a region inaccessible to immunologically competent cells of the body. The earliest successful implants, as well as a large fraction of modern ones, were in the skeletal system. Bone plates were introduced in the early 1900s to aid in the fixation of long- bone fractures. Many of these early plates broke as a result of unsophisticated mechanical design; they were too thin and had stress-concentrating corners. Also, materials such as vanadium steel that was chosen for its good mechanical properties corroded rapidly in the body and caused adverse effects on the healing processes. Better designs and materials soon followed. Following the introduction of stain- less steels and cobalt chromium alloys in the 1930s, greater success was achieved in fracture fixation, and the first joint-replacement surgeries were performed. As for polymers, it was found that warplane pilots in World War II who were injured by fragments of plastic polymethyl methacrylate (PMMA) air- craft canopies did not suffer adverse chronic reactions from the presence of the fragments in the body. PMMA became widely used after that time for corneal replacement and for replacements of sections of damaged skull bones. Following further advances in materials and in surgical technique, blood vessel replacements were tried in the 1950s and heart valve replacements and cemented joint replacements in the 1960s. Table I.6 lists notable developments relating to implants. Recent years have seen many further advances.