Cleft palate is a congenital defect that is unsightly and causes major speech and swallowing problems with the infant. This condition occurs in one out of every five hundred live births in the US. While cleft palate has both aesthetic and functional implications for patients in their social interactions, a major problem is midfacial skeletal growth that may be affected by the surgical repair of the palate. The best course would be early repair at 3 months before swallow and speech problems develop. Definitive surgical correction at this stage is often delayed because of growth issues, as the mouth will grow two times larger during childhood. An implant is needed that acts to resist pressure and allows growth in the mouth.
This surgically placed cleft implant will act as a pressure flap to allow for the negative pressures required for sucking as well as the positive pressures required for speech consonants. The implant overcomes the problems with existing implants by creating sufficient pressure sealing, fixation to the boney palate, and a loosely connected “free” edge to allow for growth. The implant is made from Salubria, a strong hydrogel patented by GT. The technology will provide the pediatric surgeon with the ability to correct the hard and soft palate at an early age to promote healthy social interactions, as well as to reduce the known developmental problems of swallowing and speech accompanying this defect.
APDC funding was used to design the implant for children and provide the Design Control documentation for FDA 510(k) application