SBIR Phase I: A Novel Suturing Device

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响和商业潜力改善了骨科韧带和肌腱重建的结果。在美国，每年有超过100万例修复撕裂韧带和肌腱的手术。然而，据报道，失败率高达25%，大多数故障归因于技术错误，这使美国医疗保健系统每年损失25亿美元。缝合被认为是手术中一个关键的、技术上复杂的步骤，如果改进，可以减少手术失败的发生率。目前的缝纫针有严重的局限性，使缝纫缓慢、乏味和不准确。在这个项目中提出的两部分针技术从根本上改变了缝合的方式。更好的质量和更快的缝合提供了改善患者预后的社会效益，以及避免与失败手术相关的成本和减少手术时间节省的商业效益。这项小企业创新研究（SBIR）第一阶段项目支持开发一种革命性的缝合设备，该设备将提高骨科韧带和肌腱修复手术的缝合能力。开创性的两部分针设计提供了提高速度和缝合质量的价值主张，这是临床成功的两个基本要素。该项目有两个主要的技术目标：首先，将构建具有可变特性的原型，并进行力测试，以确定每种特性如何影响设备的功能。该装置在缝合过程中所经历的力的性能将与传统针进行比较。其次，原型将由潜在客户构建和测试，以评估用于创建特定缝线图案的预期目的的可用性。缝线的速度和缝线图案的生物力学强度将与用传统针头创建的图案进行比较，以量化价值主张。这些目标的成功完成将极大地推动两部分针技术在骨科领域的商业化，并为其他依赖缝合的手术应用的两部分针设计的进一步研究提供基础。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.