Craniosynostosis is a condition in which one or more cranial sutures closes prematurely and occurs in approximately 1 of every 2000 live births. If left untreated, craniosynostosis can result in blindness, deafness, developmental delays and death. Treatment includes removal of entire calvaria and reconstruction but there can be up to 40% chance of re-synostosis, especially in patients under six months. This necessitates additional surgical intervention which is associated with up to a 13% risk of life threatening complications. Although recent advances have been made in understanding the genetic and molecular mechanisms involved in regulating suture fusion, there are no effective clinical therapies available to treat craniosynostosis other than complete calvarial reconstruction and there are no therapies for re-synostosis.
The hydrogel device is designed to delay regrowth of bone in the suture following surgical intervention for craniosynostosis, and provides the ability to create a functioning suture much like the natural and normal state of calvarial sutures at the age of an infant. The device is an injectable hydrogel that spontaneously polymerizes in situ and can be used at the time of the original surgery or delivered percutaneously after surgery. The hydrogel will provide a dramatic reduction in the invasiveness of the procedure, eliminating the need for blood transfusions and lengthy stays in the hospital. Another dramatic impact would be the ability to treat this condition at a much earlier age, before many of the skull deformities occur. Thus, the operation can be completed safely at a very early age and prevent as opposed to correct skull deformities.
This project was funded by the Atlanta Pediatric Device Consortium. The consortium provided advice to leverage our grant by applying to other grants. The consortium sponsors facilitated the discussions with the FDA concerning the classification of our device. When the project joined the consortium the device was in the prototyping stage of development.