Chapter category: BioMaterials
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Biomaterials in the Design and Reliability of Medical Devices
Edited by: Michael N. HelmusISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «
Chapter authors:
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be categorized as synthetic polymers (nonbiodegradable and biodegradable polymers); biologically derived materials (e.g., crosslinked xenografts); bioderived macromolecules; coatings (passive and bioactive); tissue adhesives; metal alloys; ceramics and carbons. Applications include blood-contacting devices and implants, soft tissue devices for repair and soft tissue reconstruction, orthopedic devices to aid bone repair and replace damaged bone and joints, and wound dressings for large area damage to skin from trauma, ulcers and burns. Evolving applications include the scaffolding for tissue regeneration and replacement as part of hybrid artificial organs and bioengineered tissues. Acceptable scaffolding materials for tissue engineered devices will need to not only be biocompatible in the traditional sense by allowing cellular interactions that result in tissue that mimics the naturally occurring material for which it will substitute but also from a biochemical and biomechanical perspective. Tissue engineered devices have a design requirement that the physical properties of the device meet the necessary requirements immediately and that they are maintained as either bioerodable scaffolds that are resorbed or that the tissue remodels. Tissue engineered devices may be formed on substrates of biodegradable polymers or on decellularized allografts or xenografts. Recellularization can be performed in a bioreactor or occur in situ. Growth factors and bioactive agents may be incorproated into the substrates to encourage the proper cell attachment and function. Furthermore, as living structures, adverse tissue responses such as hyperplastic responses need to be mitigated.
Additional chapters from this book:
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Tissue Engineering Constructs and Commercialization
Kelvin G.M. Brockbank
Tissue engineering is an interdisciplinary field that applies the principles of engineering (materials science and biomedical engineering) and the life sciences (biochemistry, genetics, cell and mol...
Product Development in a Small Company Environment
Roger W. Snyder
A small company, particularly a start-up operation, is an exciting, and often stressful, environment. If the company has a limited number of products, all under development, there is always pressure...
Failure Analysis: Learning for the Future from the Past
Michael N. Helmus
One of the most important tasks a medical device manufacturer can make is to have a detailed methodology in place for explant analysis. The ability to examine the device for both adverse biological ...
Nonclinical Medical Device Testing
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument...
Regulation of Medical Devices
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufactur...
Standards and Guidelines for Biocompatibility of Medical Devices
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirement...
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be ...
