SBIR Phase I: Feasibility of a novel fixation device for the repair of digital flexor and extensor tendons

This Small Business Innovation Research (SBIR) phase I project proposes to develop a novel alternative to sutures for the repair of lacerated digital flexor and extensor tendons. Over 70,000 flexor and extensor tendon repair surgeries are performed yearly in the US, often with sub optimal outcomes. The proposed technology may provide a stronger repair than the state of the art while also being faster and easier to use. The objectives of this work are to take the existing prototype for this technology and optimize the design such that certain performance metrics (including primary repair strength, bending stiffness and fatigue life) meet or exceed that of a suture repair, which is the current state of the art. The performance of the device will then be validated using an in vivo rabbit model, where efficacy will be examined at both early and late time points. Based on the preliminary work, it is anticipated that the novel device will be able to meet or exceed the current state of the art in all metrics and will demonstrate efficacy within the in vivo study. The broader impact/commercial potential of this project includes an increased level of care for patients with tendon injuries, scientific insights into the behavior of tendon repair procedures and a significant commercial impact. The current state of the art in tendon repair results in a large number of suboptimal outcomes, often leading to costly revision surgery. The proposed technology may lead to a decrease in morbidity and the number of revision surgeries. In spite of the fact that suture based repairs have been the state of the art for over one hundred years, little basic science work has been done to investigate the effect of the suture on the healing process. The proposed work will not only examine how the novel device effects the healing process in vivo, but will also examine the performance of suture in vivo. This will yield fundamental insights into the interaction between healing tendon tissue and both the device and suture. Given the substantial size of the tendon repair market, the proposed technology may also generate a considerable commercial impact. If successful, the manufacture, marketing and sales of the device could result in substantial revenue and the creation of a significant number of new jobs.