~ound C:tosure Biomaterials Devices and \^ o u n d (C lo su re Diom aterials £) and Edited by Chih-Chang Chu, Ph.D. Fiber Science Program Department of Textiles and Apparel College of Human Ecology and Bioengineering Program Cornell University Ithaca, New York J. Anthony von Fraunhofer, Ph.D., F.A.S.M., F.R.S.C. Department of Restorative Dentistry School of Dentistry University of Maryland at Baltimore Baltimore, Maryland Howard P. Greisler, M.D. Department of Surgery Department of Cell Biology, Neurobiology, and Anatomy Stritch School of Medicine Loyola University and Department of Surgery Hines V.A. Hospital Maywood, Illinois CRC Press Taylor 8i Francis Group Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business Acquiring Editor: Marsha Baker Editorial Assistant Jean Jarboe Project Editor: Gail Renard Marketing Manager: Susie Carlisle Direct Marketing Manager: Becky McEldowney Cover Designer: Dawn Boyd Pre Press: Kevin Luong Manufacturing: Sheri Schwartz Library of Congress CataJoging-ln-PubUcatlon Data Wound closure biomaterials and devices I edited by Chih-Chang Chu, J. Anthony von Fraunhofer, Howard P. Greisler. p. em. Includes bibliographical references and index. ISBN 0-8493-4964-8 I. Ligature (Surgery). 2. Sutures. 3. Adhesives in surgery. I. Chu, Chih-Chang. II. Von Fraunhofer, J. A. (Joseph Anthony). Ill. Greisler, Howard P. RD73.L5W68 1996 617'.9178-dc20 96-8975 CIP This book contains information obtained from authentic and high! y regarded sources. Reprinted material is quoted with permission, and sources are indicated. 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For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new worts, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 Corporate Blvd., N.W., Boca Raton, Aorida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. (!:) 1997 by CRC Press LLC No claim to original U.S. Government worts International Standard Book Number 0-8493-4964-8 Library of Congress Card Number 96-8975 Printed in the United States of America 2 3 4 5 6 7 8 9 0 Printed on acid-free paper CONTRIBUTORS Chih-Chang Chu, Ph.D. Yoshito lkada, D.Eng., D.Med.Sc. Professor, Fiber Science Program Professor Department of Textiles & Apparel Research Center for Biomedical Engineering College of Human Ecology and Kyoto University Bioengineering Program Kyoto, Japan Cornell University yyikada@ medeng.kyoto-u.ac.jp Ithaca, New York [email protected] William Irvin, M.D. 1030 S. Jefferson Suite 110 j. Anthony von Fraunhofer, Ph.D., F.A.S.M., Roanoke, Virginia F.R.S.C. Professor, Department of Restorative Dentistry Steven S. Kang, M.D. School of Dentistry Assistant Professor of Surgery University of Maryland at Baltimore Department of Surgery Baltimore, Maryland Loyola University Medical Center avfOO I @dental3.ab.umd.edu Maywood, lllinois skang@ wpo.it.luc.edu Howard P. Greisler, M.D. Peter H. Lin, M.D. Professor, Department of Surgery Department of Surgery Department of Cell Biology, Finch University of Health Science Neurobiology and Anatomy The Chicago Medical School Stritch School of Medicine Chicago, Illinois Loyola University [email protected] and Department of Surgery J. R. Perez-Sanz, M.D. Hines V.A. Hospital College of Medicine Maywood, lllinois University of Illinois-Chicago hgreisl @wpo.it.luc.edu Chicago, Illinois and Christ Hospital and Medical Center Mark K. Hirko, M.D. Oak Lawn. Illinois Department of Surgery and North Side Medical Center Little Company of Mary Hospital Youngstown, Ohio Evergreen Park, lllinois PREFACE Wound closure biomaterials and devices have played a critical role in human survival since the dawn of history. It is not an overstatement to say that human lives have been saved by tiny threads of silk or linen almost since the beginning of time. Wound closure biomaterials have the longest history among all biomaterials. These biomaterials and devices concern every surgeon because every surgery or wound requires the use of biomaterials to close them for successful healing. The proper closing of wounds can influence the success of surgery. Many complications, such as infection, wound dehiscence, and sinus formation can occur in the wound closure line. There are three types of wound closure biomaterials and devices: sutures, clips/staples, and tissue adhesives. Sutures are the most frequently used and have the longest history. As early as 4000 years ago, linen was used as a suture material. Since then, numerous materials like iron wire, gold, silver, dried gut, horse hair, strips of hide, bark fibers, silk, linen, and tendon have been used as suture materials. Among them, catgut and silk dominated the suture market until 1930. The introduction of synthetic polymers during and after World War II revolutionized the chemical origin of suture materials. The use of ligating clip/stapler systems in wound closure is relatively new and allows accurate apposition with minimal tension, reduced operating time, and easy removal. Further, these devices achieve good cosmetic results. Although metallic clips/staples have the longest history in this group, their use is limited to skin closure, and synthetic absorbable clips/staples have recently become the dominant player, particularly for tissues and organs beneath skin. Coover discovered tissue adhesives in the mid-1950s. Although they are not as popular as suture materials and clips/staples, particularly in the United States, they have a unique role among wound closure biomaterials. The significant advances in materials science and engi neering over the past decades provide surgeons with a wide range of choices of wound closure bioma terials with vast differences in chemical, mechanical, biological and often biodegradable properties, and clinical performance. As a result of this continuous advance in materials, the art of wound closure has become far more complex and demanding. Although there has been fragmented review literature describ ing suture materials in the past two decades, to date there has been virtually no single English-language volume that systematically and comprehensively describes all required properties of available wound closure biomaterials and devices. We believe such a comprehensive and timely reference source for surgeons in the modem health care environment is long overdue. Meeting the needs of surgeons is half of the goal of this book. Biomaterials scientists have played a crucial role in the research and development of wound closure biomaterials for the past several decades. Because of the multidisciplinary nature of wound closure biomaterials and devices, a book that will also satisfy biomaterials scientists and engineers must have ample information about structures and basic material properties, such as molecular weight, synthesis, and tensile properties, so that they can use the book as a major reference for future research and development of improved wound closure biomaterials and devices. With these goals in mind, we are introducing this book to both the medical and biomaterials science/engineering communities. The book has five basic parts: wound healing, suture materials, clips/staples, tissue adhesives, and emerging new wound closure biomaterials. It has 12 chapters with a distinct emphasis on suture materials because of their preeminence in wound closure use. Coherence within this book has been maintained by linking and cross-referencing the contents of the 12 chapters. In doing this, we feel we have avoided the common failing of many monographs that resemble a series of unrelated reviews by different authors. After the first chapter, Introduction, a review of the basics of wound healing, particularly relating to wound closure biomaterials, is given in Chapter 2. This chapter should provide readers with a reasonable background in the basic phenomena and some recent findings of wound healing that wound closure biomaterials experience all the time. Chapter 3, Surgical Needles, describes an integral part of sutures, particularly their biomechanical properties, that are frequently ignored in the published literature. Chapter 4, Classification and General Characteristics of Suture Materials, provides comprehensive classifications of suture materials in terms of size, biodegradability, physical form, and coating materials and an overview of four general characteristics that every suture material should have, namely physi caVmechanical, handling, biocompatibility, and biodegradation, if applicable. Following an overview of suture materials in Chapter 4, Chapter 5, Chemical Structure and Manufacturing Processes, provides far more detailed information about the basic chemical properties of suture materials and how they are made. This chapter is written mainly for chemists, material scientists, and engineers rather than surgeons. However, surgeons may use this chapter to acquire additional in-depth material information about the suture materials that they use every day. Chapters 6 through 8 cover the three most important properties of suture materials in great detail, i.e., mechanical, biodegradable, and biological properties. These three chapters provide the core infor mation for both the medical profession and materials scientists/engineers for their comprehensive under standing of the vast differences in the three most essential properties of suture materials. Several properties of suture materials that are often unfamiliar to the medical profession, such as viscoelasticity, carcinogenicity, and many new findings in biodegradation properties like computational chemical mod eling of the biodegradation property of absorbable suture materials and plasma surface modification of absorbable sutures to alter their biodegradation properties, are also explained in these three chapters. Chapter 9, Suture Techniques and Selection, is written primarily for surgeons and has practical information about the actual use of sutures in a variety of fields of surgery. Chapters 10, Ligating Clips and Staples, and 11, 1issue Adhesives, provide detailed technical infor mation about the other two types of wound closure biomaterials and devices. Because they are less frequently used than sutures, there are relatively few reported studies of these two alternative wound closure biomaterials and devices. However, the landscape of wound closure biomaterials and devices may change in the next century when new materials and technology emerge. Chapter 12, New Emerging Materials for Wound Closure, provides a preview of some new inventions and developments that could have major impact on wound closure biomaterials and devices in the next century. Those wound closure biomaterials that are currently used outside the United States but have not been approved by the FDA are also mentioned in this chapter. This chapter also suggests the direction of new research and development efforts in wound closure biomaterials by addressing some of the challenging problems, such as efficient control of wound infection, the promotion of wound healing via the incorporation of growth factors into wound closure biomaterials/devices, control of their biodegra dation behavior for better and more predictable wound healing in demanding clinical cases, and improved handling properties of sutures. We have done our best to provide readers with the most up-to-date and core information that we could find in the published literature. We primarily limited our database to English journals to ensure timely publication and wider appeal. A lot of the information used in this book is from the authors' own research activities over the past several decades. Some of the information provided in this book is not yet in the public domain, such as pending patents. We have also tried our best to balance the content of this book between the needs of clinicians and basic biomaterials scientists/engineers. We wrote this book with two basic goals in mind: clinicians would be provided with a book that has much practical information for their daily practice while researchers of either biomaterials science/engineering or with a medical background would find that this book has a wealth of research information for their research and development work on wound closure biomaterials and devices. Finally, we would particularly like to thank Dennis D. Jamiolkowski of Ethicon, Drs. Griffin Lewis and Walter Sabisiak of Davis & Geck, and Drs. C.K. Liu andY. Jiang of US Surgical for their continuous support with samples, some illustrations, and information. We would also like to acknowledge the graduate students, postdoctoral fellows, and interns of the editors for their research work, upon which this book is largely based. Chih-Chang Chu Cornell University Howard P. Greisler Loyola University J, Anthony von Fraunhofer University of Maryland at Baltimore DEDICATION We would like to dedicate this book to Martha A. Mutschler-Chu, Chen-Wei and Hope Ho-Hui Chu, and Shirley C. Chu, for their encour agement, patience, sacrifice, and understanding during those many evenings, weekends, and holidays that were consumed for the past two decades of RID of wound closure biomaterials that led to the publication of this book. C. C. Chu Elizabeth, whose unswerving support, understanding, and social conscience have enabled me to not become my own enemy. Howard P. Greisler Nancy, for her patience and support, and to my friends for not letting me lose my sense of humor during the writing of this book. }. Anthony von Fraunhofer