SBIR Phase II: Shape Memory Polymer Based Orthopedic Fixation Devices

The Small Business Innovation Research (SBIR) Phase II project includes the design, development and commercialization of shape memory polymer orthopedic soft-tissue fixation devices. Current soft tissue fixation devices are primarily metal or plastic screws used to attach tissue grafts to bone in repair of torn anterior cruciate ligaments (ACL). These threaded devices commonly damage the tendon during insertion; reducing the effectiveness of the surgery. Shape memory polymers are a superior solution in that they can provide a simpler, stronger, and less damaging fixation method for these tendon grafts. Essentially, a shape memory polymer device can be; (1) delivered into the body in a compacted and less invasive state, (2) self-deploy at body temperature and (3) do so without sharp edges that might damage the tissue. The proposed work has immediate commercial potential and direct societal benefit in the field of sports medicine with a significant market on the order of $210 million in ACL repair devices annually. Furthermore, the biomaterial developed for ACL reconstruction should have long-term impact on the 1.6MM orthopedic procedures performed each year to repair tendons and ligaments in knees, shoulders, and ankles and by reducing the invasiveness of surgery and improving the outcomes.