Handbook Of Polymer Applications In Medicine And Medical Devices

The design and development of tissue-engineered products has benefited from many years of clinical utilization of a wide range of biodegradable polymers. Newly developed biodegradable polymers and modifications of previously developed biodegradable polymers have enhanced the tools available for creating clinically important tissue-engineering applications. Insights gained from studies of cell-matrix interactions, cell-cell signaling, and organization of cellular components, are placing increased demands on medical implants to interact with the patient’s tissue in a more biologically appropriate fashion. Whereas in the twentieth century biocompatibility was largely equated with eliciting no harmful response, the biomaterials of the twenty first century will have to elicit tissue responses that support healing or regeneration of the patient’s own tissue. This chapter surveys the universe of those biodegradable polymers that may be useful in the development of medical implants and tissue-engineered products. Here, we distinguish between biologically derived polymers and synthetic polymers. The materials are described in terms of their chemical composition, breakdown products, mechanism of breakdown, mechanical properties, and clinical limitations. Also discussed are product design considerations in processing of biomaterials into a final form (e.g., gel, membrane, matrix) that will effect the desired tissue response.

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

Silicone materials have been widely used in medicine for over 60 years. Available in a variety of material types, they have unique chemical and physical properties that manifest in excellent biocompatibility and biodurability for many applications. Silicone elastomers have remarkably low glass-transition temperatures and maintain their flexibility over a wide temperature range, enabling them to withstand conditions from cold storage to steam autoclaving. They have high permeability to gases and many drugs, advantageous respectively in wound care or in transdermal drug delivery. They have low surface tension and remarkable chemical stability, enabling biocompatibility and biodurability in many long-term implant applications.

While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale

This chapter will present a look at the medical device market with a particular focus on the materials of construction of devices and what we can expect in new products looking ahead. A deeper look at some other trends that have an effect on the direction of the medical device industry will be done. Finally, consideration will be given to a number of global factors that can have dramatic effects on our industry.

Handbook of Polymers in Medicine combines core concepts and advanced research on polymers, providing a better understanding of this class of materials in medicine. The book covers all aspects of medical polymers from characteristics and biocompatibility, to the diverse array of applications in medicine. Chapters cover an introduction to polymers in medicine and the challenges associated with biocompatibility in human tissue, polyurethane and supramolecular polymers and their specific applications in medicine, from tissue regeneration to orthopedic surgery and cancer therapeutics. This book offers an interdisciplinary approach that will appeal to researchers in a range of disciplines, including biomedical engineering, materials science, chemistry, pharmacology and translational medicine. The book will also make a useful reference for clinicians and those in medical fields who are interested in materials for medical applications, as well as R&D groups involved in medical device design. Systematically covers individual polymer classes, from characteristics and biocompatibility to applications in biomedicine Covers a broad range of applications in medicine, such as cardiac tissue engineering, targeted drug delivery, dentistry, and more Provides an interdisciplinary review of polymers in medicine, allowing advanced students and experienced researchers in a range of biomedical and clinical fields to learn more about this fast-evolving area

Biomaterials are an indispensable element in improving human health and quality of life. Applications of biomaterials include diagnostics (gene arrays and biosensors), medical supplies (blood bags and surgical tools), therapeutic treatments (medical implants and devices), and emerging regenerative medicine (tissue-engineered skin and cartilage). Polymers, being organic, offer a versatility that is unmatched by metals and ceramics. The wide spectrum of physical, mechanical, and chemical properties provided by polymers has fueled the extensive research, development, and applications of polymeric biomaterials. The significance of polymers as biomaterials is reflected in the market size of medical polymers, estimated to be approximately $1 billion. Many of these polymers were initially developed as plastics, elastomers, and fibers for nonmedical industrial applications, but were later developed as biomedical-specific materials. With rapid growth in modern biology and interdisciplinary collaborative efforts, polymeric biomaterials are being fashioned into bioactive and biomimetic materials, with excellent biocompatibility.

Over the past 2000 years, many devices have been developed and used in the mitigation and diagnosis of diseases. The materials used in these devices have ranged from stone, wood, metal, ceramics, and most recently plastics. Medical devices have also evolved in sophistication and complexity over time. With the formalization of the scientific method in the seventeenth century such devices became more prevalent [1]. Many medical devices were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight. With the explosion of medical technology in the early twentieth century, several intermediaries had evolved between the medical device industry and the public. In 1879, Dr E.R. Squibb, in an address to the Medical Society of the State of New York, proposed the enactment of a national statute to regulate food and drugs [2]. It was not until 27 years later that the Food and Drug Act of 1906 was introduced into the Congress and signed into law by President Theodore Roosevelt [3]. At that time, devices that were harmful to human safety and health proliferated the market but regulation of medical devices by the Bureau of Chemistry (the precursor to the Food and Drug Administration—FDA) was limited to challenging commercial products only after they had been released into the market. Devices in the marketplace that were defective, adulterated, or misbranded were seized and the device manufacturers were prosecuted in a court of law, but only after the products were sold in the market and caused harm to the end users. Thus, there was a strong need for regulating the devices before they entered the marketplace. An FDA report [4], issued in September 1970, detailed as many as 10,000 injuries and 731 deaths from ineffective medical devices. The report recommended the formation of a regulatory system and body that would enforce the production and sale of safe and effective devices to the public. All medical devices already on the market would be inventoried and classified into a three-tiered system based on their criticality of end use. It also detailed requirements for records and reports, registration and inspection of establishments, and uniform quality assurance programs called good manufacturing practices (GMP). After much lobbying by the FDA, Senate bill SR 510, “The Medical Device Amendments of 1973” was introduced by Senator Edward M. Kennedy and was passed by the Senate in 1975. House bill HR 11124, introduced by Representative Paul Rogers, was passed by the House in 1976. These bills eventually became the Medical Device Amendments of 1976, and were signed into law by President Nixon. The Medical Device Amendments of 1976 became the basis for the medical device regulation in the United States to control and regulate the production of finished devices and thus the device manufacturers themselves.