Abstract
The tissue reactions to materials of the cuff of recently developed high volume, low pressure tracheostomy tubes were assessed by intra-abdominal and intra-nasal implantation in rats. Intra-abdominal implantation over a maximum of three months showed that the polyurethane and silicone was walled off by fibrous tissue and foreign body giant cells. The degree of giant cell reaction was similar to that seen about silk sutures. There was no evidence of hepatic or renal toxicity. Polyurethane foam also caused some inflammation and ulceration of nasal mucosa when it was implanted for six days. The degree of ulceration and inflammation was greater than that seen about an inert implant (cotton wool). Further, there was progression rather than reversal of these mucosal changes when the foam was removed. These findings are discussed and it is concluded that the demonstrated reactions of the tissues to the cuff material is acceptable when related to the clinical usage of these cuffed tubes.