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

这个小型企业创新研究(SBIR)第一阶段项目建议开发一种修复指屈伸肌腱撕裂的缝合线的新替代方案。在美国，每年进行的屈肌和伸肌肌腱修复手术超过7万例，结果往往不太理想。建议的技术可以提供比现有技术更强大的修复，同时也更快、更容易使用。这项工作的目标是利用这项技术的现有原型并优化设计，使某些性能指标(包括主要修复强度、弯曲刚度和疲劳寿命)达到或超过缝合修复的性能指标，这是目前的技术状态。然后，将使用活体兔子模型来验证该设备的性能，其中将在早期和后期时间点检查疗效。在前期工作的基础上，预计这种新型装置将能够在所有指标上达到或超过当前的技术水平，并将在体内研究中展示有效性。该项目更广泛的影响/商业潜力包括提高对肌腱损伤患者的护理水平，对肌腱修复程序行为的科学见解，以及重大的商业影响。目前肌腱修复的技术水平导致了大量不理想的结果，往往导致昂贵的翻修手术。拟议的技术可能会减少发病率和翻修手术的数量。尽管基于缝线的修复已经是一百多年来的最新技术，但很少有基础科学工作来研究缝合对愈合过程的影响。这项拟议的工作不仅将检验这种新型装置如何影响体内的愈合过程，还将检验体内缝合的性能。这将对愈合肌腱组织与装置和缝合线之间的相互作用产生基本的见解。鉴于肌腱修复市场的巨大规模，拟议中的技术也可能产生相当大的商业影响。如果成功，该设备的制造、营销和销售可能会带来可观的收入，并创造大量新的就业机会。

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.