Development of a polyurethane percutaneous access device for long-term vascular access.

The percutaneous placement of intravascular devices creates a portal for microbial invasion that can result in local infections or septicemia. In nature, resistance to "exist site" infection in percutaneous organs, such as teeth, is prevented by a dense collagen/epithelial barrier. A new percutaneous access device has been developed that incorporates a porous polyurethane "button" at the subdermal level. This device promotes the development of a collagen/epithelial interface, thus inhibiting sinus formation. Twelve percutaneous access devices (PCADS) were implanted in calves; eight devices were utilized for venting of, and hard wire passage to, an implantable left ventricular assist device (LVAD) and served as controls. Four devices were utilized for long-term vascular access. The PCADS remained in situ for 2-127 days (mean 70). Excellent healing was apparent in all cases, and no exit site or catheter related infections occurred. Histologic examination demonstrated fibroblastic in-growth and collagen deposition within the porous polyurethane, which provides a barrier to epithelial migration and firmly anchors the device. These PCADS appear to reduce exit site infections and may improve upon currently available long-term vascular access catheters.