BioMaterials
Chapters
Additives in Biomedical Polyurethanes
Nathalie Dubé, Sahar Al–Malaika, Gaétan Laroche, and Patrick Vermette
In the preceding Chapter, industrial production of polyurethanes (PUs) was covered. The main industrial processes and sterilization techniques that apply to biomedical polyurethanes were discussed. However, the issue of using polymer additives during the preparation of commercial polyure...
Biocompatibility of Polyurethanes
Yves Marois and Robert Guidoin
In the last 50 years, the development and the conception of biomaterials used for the construction of prostheses and medical devices has expanded very rapidly. A wide variety of biomaterials are now commonly implanted in the human body for the treatment of various diseases such as hea...
Biomedical Applications of Polyurethanes
Mylène Bergeron, Stéphane Lévesque, and Robert Guidoin
Polyurethanes (PUs) represent a very broad family of polymers. They have earned an enviable and irreplaceable position within the medical industry. The applications of PUs are limitless. However one should ascertain that PUs are indeed the best materials to manufacture devices for spe...
Biomedical Degradation of Polyurethanes
Patrick Vermette, Stéphane Lévesque, and Hans J. G
As discussed in the preceding Chapter, polyurethanes (PUs) generally show relatively acceptable biological responses, which have frequently led to statements that they are biocompatible. However, many researchers have pointed out a need for improved performance in some applications, s...
Commercial Production of Polyurethanes
Stéphane Lévesque, Denis Rodrigue, Patrick Vermette, and Pathiraja Gunatillake
As discussed in the preceding Chapter, polyurethanes (PUs) involve relatively complexchemistry and synthesis procedures compared to other conventional polymers used in biomedical applications. To meet the task of engineering PU–based devices and implants that fulfil the requirements...
Developments in Design and Synthesis of Biostable Polyurethanes
Pathiraja A. Gunatillake, Gordon F. Meijs, and Simon J. McCarthy
Synthetic elastomers are frequently the materials of choice for the construction ofimplantable medical device componentry. To function effectively, the chemical and mechanical properties of the polymer must be suitable for the intended application. The polymer must also have character...
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 responses and for durability related to fatigue, corrosion, and degradation mechanisms is an import...
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, apparatus, appliance material or other article intended by the manufacturer to be used for human ...
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 categorized as synthetic polymers (nonbiodegradable and biodegradable polymers); biologically deriv...
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 to get those products to market as soon as possible to generate sales and income. If the new devic...
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 manufacturer may follow in order to obtain approval or clearance to market products in the U.S. Many of the s...
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 requirements for regulated health care products requires even more attention to regulatory strategy. This Chap...
Surface Modification of Polyurethanes
Hans J. Griesser
Why perform surface modification of polyurethanes (PUs) when numerous publications and patents claim "biocompatible" and "blood compatible" PUs? The simple answer is that some claims are exaggerated and others only applicable to specific situations. While the mechanical properties (such ...
Synthesis, Physicochemical and Surface Characteristics of Polyurethanes
Martin Castonguay, Jeffrey T. Koberstein, Ze Zhang, and Gaétan Laroche
This Chapter constitutes the starting point that will bring the reader to the other subjects discussed in this book as, for example, the biological response and biostability related to polyurethanes (PUs) are primarily driven at the first steps with their Synthesis and processing. Many l...
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 success of traditional materials in many medical devices is unsatisfactory. Specifically, the recip...
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 success of traditional materials in many medical devices is unsatisfactory. Specifically, the recip...
The Future of Polyurethanes
Robert Guidoin and Hans J. Griesser
Where would implantology and the biomedical devices industry be today if it were not for synthetic polymeric biomaterials such as polyurethanes? While "natural" biopolymers such as reconstituted collagen have made essential contributions to the viability of some biomedical devices, synth...
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 molecular biology) to the development of biological substitutes that can restore, maintain, or improve...
