SBIR Phase I: Dynamic Night Splint

Kenai Design, Llc, Newtown CT

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is improved care for plantar fasciitis (PF), an inflammation of the fibrous tissue (plantar fascia) along the bottom of the foot connecting the heel bone to the toes. This progressive degenerative condition results in stabbing, sometimes debilitating, pain. Plantar fasciitis is most common in athletes, but it also occurs in sedentary people, particularly overweight individuals, and is the most common cause of heel pain in adults, with an estimated lifetime risk of 10%. In the US, approximately 2-3 million patients are treated for PF every year and it is the leading reason to visit a podiatrist. Conservative treatments of PF are moderately successful, but 20% to 30% of patients progress to a chronic condition that can last years and is difficult to treat. The proposed dynamic night splint is intended to accelerate healing relative to conventional splinting technologies and to improve patient compliance and prognosis. This can potentially be used for other medical conditions where controlled motion is better than a static constraint. This Small Business Innovation Research (SBIR) Phase I project integrates miniature electromechanical components, “internet-of-things” technology, and a patient-centric approach to medical device design to achieve a re-imagined night splint. The concept enables a shift from rigid constraint of the injured tissue to actively manipulating the tissue to accelerate recovery. To achieve a clinically viable solution this will address competing requirements, including incorporation of dynamic components, a control and power system, an intuitive user interface, and reliable safety features, while minimizing the form factor and maximizing patient comfort. This Phase 1 project designs and fabricates the night splint with the necessary elements (a leg engaging flexible “boot” structure, an electromechanical drive system, and a mobile app user interface) to validate the design through bench testing and user assessments. 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.