Voice prosthesis for laryngectomy patient - is one piece hollow member in silicone with specified parameters and inserted via oesophagus

摘要

Prosthesis consists of a one-piece hollow member in medical-guide silicone elastomer which is placed in a duct (fistula) between the trachea and the oesophagus. This member comprises a domed membrane with incision to form a valve with 14 mm diameter and 4 mm maximum height, a tubular portion 3-12 mm long depending on the size of the fistula, a 12-14 mm diameter flange to locate in the trachea, and a pull string around 4 cm long for engagement by forceps during insertion. Silicone material has 30-35 Shore A hardness, 700-800% stretchability, 160-200 Die B ppi tear strength and 1000-1250 psi tensile strength.