Biocompatibility of a novel tissue connector for fixation of tracheostoma valves and shunt valves

Rehabilitation after laryngectomy often includes the use of a shunt valve a nd a tracheostoma valve to restore voice. To improve the fixation method of these valves, a new tissue connector has been developed, basically consist ing of a ring that will be integrated into surrounding tracheal soft tissue . The valves can be placed in the ring. To test the principle of the tissue connector, a prototype consisting of a subcutaneous polypropylene mesh and a percutaneous titanium stylus was implanted into the backskin of 10 rats by a two-stage surgical procedure. We reasoned that if a firm connection ca n be realized with the skin, a firm connection with the trachea will also b e possible. The subcutaneous part was implanted first, followed by the perc utaneous part after 6 weeks. The complete tissue connector with surrounding tissue was removed 8 weeks later and examined histologically. The principl e of the new tissue connector proved to be effective: hardly any epithelial downgrowth appeared, and adhesion of soft tissue was demonstrated. No infe ction or severe inflammation reaction was detected. The tissue connector se ems appropriate for its intended use. (C) 1999 Elsevier Science Ltd. All ri ghts reserved.