Biocompatibility factors

Implant retrieval and evaluation plays a significant role in determining biocompatibility, factors and mechanisms of medical device failure or success, and new biological design criteria for next-generation devices. ... 

A surface is that part of an object which is in direct contact with its environment and hence, is most affected by it. The surface properties of solid organic polymers have a strong impact on many, if not most, of their apphcations. The properties and structure of these surfaces are, therefore, of utmost importance. The chemical stmcture and thermodynamic state of polymer surfaces are important factors that determine many of their practical characteristics. Examples of properties affected by polymer surface stmcture include adhesion, wettability, friction, coatability, permeability, dyeabil-ity, gloss, corrosion, surface electrostatic charging, cellular recognition, and biocompatibility. Interfacial characteristics of polymer systems control the domain size and the stability of polymer-polymer dispersions, adhesive strength of laminates and composites, cohesive strength of polymer blends, mechanical properties of adhesive joints, etc. 

Applicability in biological ion assay is an important factor for biocompatible potentio-metric ion sensors. Attempts were made to determine Na" " concentrations in human blood sera by using silicone-rubber membrane Na+-ISFETs based on (5) [Fig. 17(a)] [29]. The found values for Na concentration in undiluted, 10-fold diluted, and 100-fold diluted serum samples are in good agreement with the Na" " calibration plots. Even in the undiluted serum samples, only a slight potential shift was observed from the calibration. This indicates that the calixarene-based silicone-rubber-membrane Na+-ISFETs are reliable on serum Na assay. For comparison with the silicone-rubber membrane, Na -ISFETs with corresponding plasticized-PVC membrane containing (2) or (5) were also tested for the Na assay. The found values of Na" " concentration... 

The main advantage is that the entrapment conditions are dictated by the entrapped enzymes, but not the process. This includes such important denaturing factors as the solution pH, the temperature and the organic solvent released in the course of precursor hydrolysis. The immobilization by THEOS is performed at a pH and temperature that are optimal for encapsulated biomaterial [55,56]. The jellification processes are accomplished by the separation of ethylene glycol that possesses improved biocompatibility in comparison with alcohols. 

Nanoparticle surface modification is of tremendous importance to prevent nanoparticle aggregation prior to injection, decrease the toxicity, and increase the solubility and the biocompatibility in a living system [20]. Imaging studies in mice clearly show that QD surface coatings alter the disposition and pharmacokinetic properties of the nanoparticles. The key factors in surface modifications include the use of proper solvents and chemicals or biomolecules used for the attachment of the drug, targeting ligands, proteins, peptides, nucleic acids etc. for their site-specific biomedical applications. The functionalized or capped nanoparticles should be preferably dispersible in aqueous media. 

The interaction in an interface of device/tissue is limited by two factors. There is the corrosive environment, such as biological fluid, which contains salts and proteins among other cellular structures in which the sensor device must survive [47, 48], Second, there is the encapsulation material which may induce a toxic reaction due to poor biocompatibility and hemocompatibility [49, 50], It is crucial to use a biomaterial that can overcome both limiting factors to maintain the lifetime of the sensor device and protect the body [51, 52],... 

Polyvinyl alcohol (PVA), which is a water soluble polyhidroxy polymer, is one of the widely used synthetic polymers for a variety of medical applications [197] because of easy preparation, excellent chemical resistance, and physical properties. [198] But it has poor stability in water because of its highly hydrophilic character. Therefore, to overcome this problem PVA should be insolubilized by copolymerization [43], grafting [199], crosslinking [200], and blending [201], These processes may lead a decrease in the hydrophilic character of PVA. Because of this reason these processes should be carried out in the presence of hydrophilic polymers. Polyfyinyl pyrrolidone), PVP, is one of the hydrophilic, biocompatible polymer and it is used in many biomedical applications [202] and separation processes to increase the hydrophilic character of the blended polymeric materials [203,204], An important factor in the development of new materials based on polymeric blends is the miscibility between the polymers in the mixture, because the degree of miscibility is directly related to the final properties of polymeric blends [205],... 

Any material proposed for implantation, whether for cell transplantation or some other application, must be biocompatible i.e. it must not provoke an adverse response from the host s immune system. If this goal is not met the implant may be rejected. To this end it is important that the material be easily sterilized either by exposure to high temperatures, ethylene oxide vapor, or gamma radiation. A suitable material must therefore remain unaffected by one of these three techniques. However, biocompatibility is not simply a question of sterility. The chemistry, structure, and physical form of a material are all important factors which determine its biocompatibility. Although our understanding of the human immune system is advancing rapidly, it is not yet possible to predict the immune response to a new material. This can only be determined by in vivo experiments. 

Figure 4.18 Theoretical values of the shape factor for ellipsoids. Adapted from F. H. Silver and D. L. Christiansen, Biomaterials Science and Biocompatibility, p. 150. Copyright 1999 by Springer-Verlag.

This section will review how physiological factors at the site of injection impact the design of dosage forms and affect choice of excipients. First, pharmacokinetic factors affecting rates of delivery of drug to the blood will be considered. Then, biocompatibility or safety issues will be addressed. This analysis focuses on the intravascular (IV), IM, and SC routes of administration. 

One method of producing a biocompatible surface is to prevent adsorption of proteins. If proteins adsorb or otherwise become attached to a polymer surface, the attachment can interfere with the normal cell functions. The interaction of a polymer surface and blood is equally problematic. A component in blood known as the Hageman factor detects hydrophobic surfaces. The signaling involves attachment of the factor to the surface and by the process of attachment, the factor becomes activated. This is the first step in the inflammation response that can lead to rejection. Thus, the development of a hydrophilic surface with minimal protein adsorption may become a strategy for the development of compatible medical devices. 

The major factors impacting sensor performance, whatever the physiological basis, are the degree of local vascularity and the loss of functional microvessels, together with the eventual presence and thickness of a fibrous capsule. Continued inflammation and collagen deposition eventually reach an equilibrium state, and the thickness of the fibrous capsule has been proposed as an index of biocompatibility.32 The thickness and vascularity of the capsule depend on the size, surface texture, and porosity of the implant.33-35... 

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