SBIR Phase II: A Novel Suturing Device

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是通过开发一种新的缝合技术来改善骨科软组织手术后的结果。有效的缝合是韧带和肌腱手术成功的关键。这些手术需要专业和技术复杂的缝合技术，并在常规和常规的基础上进行。在美国，每年进行的韧带和肌腱手术超过100万例，其中7.5%由于移植物或缝合问题需要进行一次或多次修复。这项创新利用了两部分针技术，以提高手术一致性，减少每次手术所需的手术时间。该设计使手术缝合以一种新颖的方式实现基于个人需求的多种模式，同时减少了近2/3的手术修改需求和执行每个程序所需的时间。这个小企业创新研究（SBIR）二期项目进一步研究和开发一种用于骨科韧带和肌腱手术的新型缝合设备。两部分针设计基于集成结设计，用于增加紧固机械完整性，同时减少手术变异性和持续时间。第一个技术里程碑包括设计优化和验证，以证明系统在各种解剖和手术（脚踝、肘部和膝盖）上优于当前临床标准。生物力学和尸体模型将表明手术成功。第二个里程碑将使用类似的方法开发和测试几个新的实施例（大小和形状），以便更广泛地采用。新设计旨在使系统能够用于目前单零件针设计配置无法实现的新程序。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 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.