Fluoropassivation and gelatin sealing of polyester arterial prostheses to skip preclotting and constrain the chronic inflammatory response.

Fluoropassivation and gelatin coating have been applied to polyethylene terephthalate (PET) vascular prosthesis to combine the advantages of both polytetrafluoroethylene (PTFE) and PET materials, and to eliminate the preclotting procedure. The morphological, chemical, physical, and mechanical properties of such prostheses were investigated and compared with its original model. Fluoropassivation introduced -OCF(3), -CF(3), and -CFCF(2)- structures onto the surface of the polyester fibers. However, the surface fluorine content was only 28-32% compared to the 66% in expanded PTFE (ePTFE) grafts. The fluoropassivation decreased the hydrophilicity, slightly increased the water permeability, and marginally lowered the melting point and the crystallinity of the PET fibers. After gelatin coating, the fluoropassivated and nonfluoropassivated prostheses showed similar surface morphology and chemistry. While gelatin coating eliminated preclotting, it also renders the prostheses slightly stiffer. The original prosthesis had the highest bursting strength (275 N), with the fluoropassivated and gelatin-sealed devices showing similar bursting strength between 210 and 230 N. Fluoropassivation and gelatin coating lowered the retention strength by 23 and 30% on average, respectively. In vitro enzymatic incubation had only marginal effect on the surface fluorine content of the nongelatin-sealed prostheses. However, the gelatin-sealed ones significantly lost their surface fluorine after in vitro enzymatic incubation (by 69-85%) or in vivo 6-month implantation (by 51-60%), showing the lability of the fluoropolymer layer under the hostile biological environment.