SBIR Phase I: Tendon-Implant Integration in a Tendon-Mounted Implant for Reconstructive Surgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel medical device approach for restoring movement and recovery during reconstructive surgery. The surgically implanted system integrates a differentiated mechanical approach for redirecting internal forces and movement transmission of the tendons and ligaments in order to restore articulation and strength. The overall objective is to develop an implatable system capable of chronically integrating lateral movement from a tendon-mounted implant and two tendons, to reroute movement from a single tendon to multiple tendons. If successful, the system will provide greater restorative function to grip strength and rehabilitative compensation of arm movements following reconstructive surgeries due to a vatiery of neuromuscular conditions including but not limited to spinal cord injury or nerve trauma. The new implantable approach aims to improve surgical functional outcomes for over 100,000 patients each year through improved manual dexterity and recovery. This Small Business Innovation Research (SBIR) Phase I project advances the design engineering and preclinical evidence validation for a small implantable medical device with an integrated passive swiveling mechanism using biological tendons. The first stage will complete design and fabrication of the prototype incorporating biomechanical grooves and pores to facilitate tendon in-growth. The second stage will validate the design with a chronic lapine study of lateral integration between a tendon-mounted implant and two tendons in order to reroute movement from a single tendon to multiple tendons. Upon surgical implantation, the device-tendon construct aims to distributes movement from one muscle across multiple output tendons, while allowing each tendon to reach its own tension equilibrium. A histological and mechanical evaluation to will be performed on the tendon-implant attachment to demonstrate chronic feasibility. It is expected the implant will significantly improve function, integrate with the tendons, and not adversely impact tendon health. Upon completion, the design and preclinical evidence will be integrated into a product design plan to reach human use during the subsequent stage. 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.