SBIR Phase II: Mimicking Metatarsophalangeal Joints Using Tailored, Ultra-Dissipative, Liquid-Crystalline Elastomers to Treat Hallux Rigidus

The broader impact of this Small Business Innovation Research (SBIR) Phase II project stems from its potential to treat arthritis in joints. This research will be the first investigation into the use of liquid-crystal elastomers (LCEs) for joint repair to treat hallux rigidus. Hallux rigidus (HR) is a joint disorder at the base of the big toe affecting approximately 2.5% of people over 50 years old and roughly 2-3 million people in the US. It is the second most common condition for the metatarsophalangeal (MTP) joint. If successful, this LCE-based MTP joint implant would advance the standard of care in treating joint degeneration and open the way for novel uses of LCEs in the body. The unique nature of LCEs will permit devices to mimic the natural tissues in the body and provide anatomically correct support. In addition to LCE's ability to mimic the MTP joint, other potential advantages may lead to the advancement of patient-specific devices such as treatments for arthritis in other joints in the foot, hand, knee (e.g., total knee replacement), and spine (e.g., total disc replacement). Other soft tissue applications include osteochondral defects (OCD) and the repair of any load-bearing orthopedic tissue such as meniscus. The proposed project focuses on developing, verifying and validating, and commercializing an LCE-based cartilage replacement device for the MTP joint to treat hallux rigidus. LCEs have superior energy dissipation properties relative to traditional elastomers such as silicone or hydrogels. This proposal seeks to demonstrate how LCEs can be used to treat degenerated joints by combining the fields of liquid-crystal elastomers, rheology, and bioengineering. LCEs are known for their unique behavior which is similar to biological tissues. This project will be accomplished through several main research objectives to support and accelerate the research and development effort: completion of the device pilot production, verification and validation, development of surgical kits and procedures for the device, and transfer of the technology into high volume manufacturing for the commercial device launch. 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.