SBIR Phase II: A Novel Suturing Device

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve outcomes following orthopedic soft tissue surgeries through the development of a novel stitching technology. Effective stitching is essential for successful outcomes in ligament and tendon surgery. These surgeries require specialized and technically complex stitch techniques and are performed on a regular and routine basis. More than 1 million ligament and tendon surgeries are performed in the United States each year, with 7.5% requiring one or more revisions due to graft or stitching issues. This innovation utilizes a two-part needle technology in order to improve surgical consistency and reduce surgical times needed for each procedure. The design enables surgical stitching in a novel manner to enable a multitude of patterns based on the individual needs, while reducing the need for surgical revisions by nearly 2/3 and time needed to perform each procedure by 1/3. This Small Business Innovation Research (SBIR) Phase II project furthers research and development of a novel suturing device for orthopedic ligament and tendon surgical procedures. The two-part needle design is based on integrated knot designs and is used to increase fastening mechanical integrity while reducing surgical variability and durations. The first technical milestone includes design optimization and validation to demonstrate system superiority over the current clinical standard across various anatomies and procedures (ankle, elbow, and knee). Biomechanical and cadaver models will be indicative of procedural success. The second milestone will develop and test several new embodiments (size and shape) for enabling wider adoption, using a similar methodology. The new design aims to enable system use for new procedures that are currently inaccessible with the current single part needle design configuration. 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.