SBIR Phase I: Shape-Memory Fabric Device for Muscle Atrophy in Rotator Cuff Repair

This Small Business Innovation Research (SBIR) Phase I project aims to develop a mechanically-active soft tissue reinforcement device using a shape-memory fabric to improve the tissue quality of chronic rotator cuff tears. With chronic tears, the rotator cuff has degenerated to a point that prevents its ability to heal back to bone using standard repair procedures. The intellectual merit of this project stems from using the shape-memory effect to apply a continuous force on the atrophied rotator cuff tissue in an effort to promote tissue regeneration and improve the overall healing capacity. The research for this project will focus on evaluating (1) how the physical attributes of the fabric will impact the shape-memory properties and (2) the effect of applying a force, generated by the fabric?s shape recovery, on the quality of the rotator cuff tissue. The anticipated results of this work will be the identification of a fabric that can contract via shape recovery at body temperature over a time scale required for soft tissue reattachment to occur. This work will also demonstrate that tension can be continuously applied to cuff tissue at a magnitude representative of physiological tensile loading on the cuff. The broader impact/commercial potential of this project is the potential to address a significant clinical problem pertaining to the treatment of chronic rotator cuff tears. Over 400,000 rotator cuff repairs are performed each year, but have a failure rate of 20%. The rotator cuff reinforcement device market is estimated to be $91 M and growing 16% annually. There are currently no reinforcement devices commercially available that can help improve tissue quality in chronic cuff tears. Thus, a reinforcement device that can apply continuous tensile force to improve tissue quality could serve as a disruptive technology in a large market and significantly impact how rotator cuff procedures are performed. From a technological/scientific standpoint, this project will provide the fundamental knowledge of how shape-memory materials can be applied to mechanically stimulate a biologic response in vivo, specifically the effect of tensile force on soft tissue regeneration. In addition, this shape-memory fabric technology could broadly lend itself to other clinical applications including Achilles tendon repair, hernia repair, battle-field/traumatic muscle injuries, and muscular disorders.