SBIR Phase I: A Novel Suturing Device

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project improves outcomes following orthopedic ligament and tendon reconstruction. More than 1 million surgeries to repair torn ligaments and tendons are performed in the United States annually. However, the failure rates are reported to be as high as 25% and the majority of failures are attributed to a technical error, which costs the US healthcare system $2.5 billion each year. Stitching has been identified as a critical, technically complex step in the surgery that, if improved, can be a way to reduce the incidence of failure. Current stitching needles have serious limitations that make stitching slow, tedious, and inaccurate. The two-part needle technology proposed in this project fundamentally changes how stitching can be performed. Better quality and faster stitching provides a societal benefit of improved patient outcomes as well as commercial benefits of avoided costs associated with failed surgeries and savings from reduced procedure times. This Small Business Innovation Research (SBIR) Phase I project supports development of a revolutionary suturing device that will advance stitching capabilities for orthopedic ligament and tendon repair surgery. The groundbreaking two-part needle design offers a value proposition of improved speed and quality of stitching, two essential elements for clinical success. This project has two overarching technical objectives: First, prototypes will be constructed with variable characteristics, and force testing will be performed to determine how each characteristic impacts functionality of the device. Performance of the device with regards to forces experienced during stitching will be compared to conventional needles. Second, prototypes will be constructed and tested by potential customers to assess usability for the intended purpose of creating specific stitch patterns. Speed of stitching and biomechanical strength of the stitch patterns will be compared to patterns created with conventional needles to quantify the value proposition. Successful completion of the objectives will substantially advance the two-part needle technology toward commercialization in orthopedics and provide a basis for additional research of the two-part needle design for other surgical applications that rely on stitching. 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.