SBIR Phase I: Miniaturization of a Magnetic Craniofacial Distraction System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve surgical outcomes for the more than 200,000 newborns worldwide who are born each year with congenital conditions that cause impaired growth of the skull or mandible. These abnormalities affect breathing, hearing, speech, visual function, neurologic development, and mastication. Current treatments for this fragile population are inherently complex and traumatic. Distraction osteogenesis (DO) is a widely recognized treatment modality for craniofacial abnormalities that harnesses the body’s natural ability to regenerate bone in order to correct skeletal deficiencies and defects. While surgeons have shown the utility of DO for restoring functional discrepancies in patients born with craniofacial differences, the technique has not been widely adopted due to limitations of current DO systems, including their semi- buried design and burdensome reliance on caregivers to follow precise treatment protocols. This project will further development of a novel distraction technique that will address many of these issues. Beyond the initial DO indication, eventual applications in surgical correction of obstructive sleep apnea and temporomandibular joint (TMJ) disorder represent an eventual market potential of at least $6 B. This Small Business Innovation Research (SBIR) Phase I project will further development of a novel contactless implant and associated external driver that will significantly improve upon current distraction osteogenesis (DO) surgical apparatus by removing a principal path to device-associated complications and treatment noncompliance. The current standard of care includes an external component that protrudes through the patient’s skin; this is required for manual expansion of the device. The device package to be developed in this proposal will eliminate the protruding component through use of an innovative design that leverages magnets instead of manual action to produce the force necessary for distraction. This will not only remove a pathway to infection but also will resolve many of the other limitations associated with the standard of care such as the increased risk of device dislodgement, analgesic use, patient stigma, required manual operation, and treatment noncompliance. This project will build on early proof-of-concept work to model, produce and then test a set of device prototypes, with critical dimensions no larger than standard of care, to rigorously demonstrate that they can meet key performance specs; in particular that they can provide the distraction force necessary to enable a new and entirely contactless DO procedure. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.