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This Defense Intelligence Agency reference document, dated 7 January 2010 and prepared under the Acquisition Threat Support series, surveys biomaterials used in medicine. It covers biocompatibility, biosensor membranes, silicones, Teflon, biodegradable polymers, hydrogels, titanium, bioceramics, tissue constructs, cardiovascular stents, contact lenses, drug delivery and dialysis. It concludes that biomaterial performance underlies many medical devices, that the industry is slow to adopt new materials because of testing costs, and that innovation mainly involves new applications of established materials.
UNCLASSIFIED/71P8R: 8PPil!IJIIL -,!II! 8HLY laboratory, in processing biomolecules in biotechnology, for fertility regulation implants in cattle, in diagnostic gene arrays, in the aquaculture of oysters, and for investigational cell-silicon "biochips." The common thread in these applications is the interaction between biological systems and synthetic or modified natural materials. Biomimetic materials, in contrast, are not made by living organisms but have compositions and properties similar to materials made by living organisms. For example, the calcium hydroxyapatite coating found on many artificial hips-used as metal-bone interface cement to make it easier to attach implants to bone-is similar to the coating found in mollusk shells. IMPORTANCE OF BIOCOMPATIBILITY Biocompatibility is an important issue in biomedical implants and sensors. A material-tissue interaction that results from implanting a foreign object in the body is a major obstacle to developing stable and long-term implantable devices and sensors. The processes that occur when sensors are placed in the complex living environment of the human body are sometimes known as biofouling. In biofouling, the physical or chemically sensitive portion of the sensor interface becomes coated with proteins, blood-formed elements, adherent immunological cells, and sometimes forms of scar tissue that tend to isolate the sensor from the rest of the body environment. This response of tissue is a foreign body reaction to any object introduced in tissue that does not express surface characteristics that identify it as pa rt of the host tissues. Experiences of many investigators (more than 600 reported studies since 1996) with the biocompatibility of biomaterials related to the function of implanted biosensors have been poor such that many companies have abandoned implantable sensor devices altogether. Rather, the recent trend in medical biosensors is toward placing them outside the body. Newer sensors are often based on optical principles in an effort to obviate the biocompatibility and biomaterial issues of placing sensors inside the human body. SCIENCE OF BIOMATERIALS The study and use of biomaterials bring together researchers from diverse academic backgrounds who must communicate clearly. Professions that intersect in the development, study, and application of biomaterials include bioengineer, chemist, chemical engineer, electrical engineer, mechanical engineer, materials scientist, biologist, microbiologist, physician, veterinarian, ethicist, nurse, lawyer, regulatory specialist, and venture capitalist. The number of medical devices used each year in humans is very large. Figure 2 estimates usage for common devices, all of which employ biomaterials. vii UNCLASSIFIED/iJF811 llffllillaP!I!! Y81!! SUL I
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Report, from the dia collection. The PDF is mirrored here; the original link is above. 32 pages are in the text index: search them above, or from the library's search.