Use of Supercritical Fluid Extraction as a Method of Cleaning Anterior Cruciate Ligament Prostheses In Vitro and In Vivo Validation

Abstract

The process of supercritical fluid extraction (SFE) using carbon dioxide as the mobile phase is finding increasing numbers of applications in a wide variety of industries for the extraction, separation, and cleaning of materials. This study assessed the usefulness of this approach in removing surface contaminants from a knitted polyester anterior cruciate ligament (ACL) prosthesis before packaging and sterilizing the product during manufacture. The physical, dimensional, and chemical properties of SFE treated compared with commercially scoured control samples were characterized using a number of textile test methods: electron spectroscopy for chemical analysis, Fourier transform infrared spectroscopy, differential scanning calorimetry, and solvent extraction analysis. The bio-compatibility of the samples was measured in terms of their ability to generate CD18 integrin expression on activated human polymorphonuclear cells, and their inflammatory response when implanted for up to 30 days in the knee joint of rats. SFE treatment was successful in removing most of the nonpolar contaminants from the ACL prosthesis and reducing the amount of residuals to a commercially acceptable level. However, some nitrogen containing compounds and polar salts were not removed by the SFE process. The results from the biocompatibility tests demonstrated that the cleaner SFE treated prosthesis induced significantly lower CD18 expression than the scoured control fabric, and was also associated with a milder inflammatory response and a more rapid rate of healing during the 30 day animal trial. Another effect of SFE processing was to cause the polyester device to shrink and lose porosity because of yarn contraction and modification of the polymer's microcrystalline structure. ASAIO Journal 1998; 44:278–288.