Development of a new percutaneous access device for implantation in soft tissues

The objective of this study was to evaluate a new type of percutaneous device (PD) designed to be implanted in soft tissues. The new PD consisted out of: (1) a flange-shaped subcutaneous component, made from sintered titanium fiber-web, and (2) a percutaneous component, made from dense sintered hydroxyapatite. The PDs were inserted in the back of 15 rabbits. The surgical procedure was performed in two steps. In the first session the subcutaneous component was placed. In the second session, after 3-4 months the percutaneous component was fixed in the subcutaneous component. The implants were left in situ for 1 and 4 months after the second implantation session. Clinical and histological investigations were performed. It is found, that there was only a limited epidermal down-growth in the percutaneous area. No inflammatory reaction was observed in the dermal connective tissue. Histological analysis also demonstrated that titanium fiber mesh evokes minor adverse effects of the surrounding tissues. In conclusion, these experiments have shown that stabilization of the PD in the hypodermal area by using a sintered titanium fiber-web structure favors the longevity of PDs implanted in soft tissues.