STTR Phase I: Development of a Novel Surgical Navigation System for Total Knee Replacement

该小型企业技术转让计划（STTR）I期项目的更广泛影响/商业潜力是显著改善骨科护理，与（1）通过显著降低成本，广泛扩大患者对改进手术的使用;（2）通过患者特定手术干预获得更好的结局。现有的先进手术导航技术未能满足医疗保健提供者的临床需求和财务现实，导致采用率较低，尽管骨科医生、医院和患者对先进技术解决方案有需求。尽管临床结果上级，但目前在美国进行的关节置换手术中，只有不到15%采用了先进技术，这为解决未满足的市场需求提供了重要的商业机会，到2026年全球市场需求将达到50亿美元。所提出的技术从根本上降低了先进手术导航系统的成本，并改善了结果。 小企业技术转让计划（STTR）第一阶段项目的重点是开发领先的低成本手术导航，以帮助骨科医生为所有关节置换患者实现精确、个性化的植入物匹配和放置。现有的用于关节置换的导航和机器人系统具有较高的前期和经常性成本。它们增加了外科手术的时间和复杂性，并且需要额外的和更大的切口来容纳用于将跟踪器固定到患者骨骼的侵入性销。该系统采用先进的3D扫描技术来绘制患者解剖结构，并采用专有的雷达跟踪技术来帮助外科医生为每位患者理想地安装和放置植入物。该项目第一阶段旨在实现以下技术目标：（1）验证高分辨率雷达跟踪精度，（2）实现3D扫描以将患者成像数据配准到其解剖结构，以及（3）通过关节和相关软组织的解剖计算模型，验证手术计划系统，为每位患者提供个性化手术。该奖项反映了NSF的法定使命，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 Technology Transfer Program (STTR) Phase I project is the significant improvement in orthopedic care associated with (1) the broad expansion of patient access to improved procedures through significant cost reduction; and (2) better outcomes through patient-specific surgical interventions. Existing advanced technology for surgical navigation has failed to address the clinical needs and financial realities for healthcare providers, resulting in a low adoption rate, despite demand from orthopedic surgeons, hospitals, and patients for advanced technology solutions. Less than 15% of joint replacement surgeries performed in the United States today utilize advanced technology, despite superior clinical outcomes, presenting a significant commercial opportunity to address an unmet market need that will reach $5 billion globally by 2026. The proposed technology radically reduces the cost of an advanced surgical navigation system and improves outcomes. This Small Business Technology Transfer Program (STTR) Phase I project focuses on developing leading-edge, low-cost surgical navigation to help orthopedic surgeons achieve precise, personalized implant fit and placement for all joint replacement patients. Existing navigation and robotic systems for joint replacement have high upfront and recurring costs. They add time and complexity to the surgical procedure and require additional and larger incisions to accommodate invasive pins used to affix trackers to the patient's bones. The proposed system utilizes advanced 3D scanning to map patient anatomy and proprietary radar tracking technology to help surgeons fit and place implants ideally for each patient. This phase I project aims to achieve the following technical objectives: (1) validation of high resolution radar tracking accuracy, (2) implementation of 3D scanning to register patient imaging data to their anatomy, and (3) validation of a surgical planning system to personalize the procedure to each patient using an anatomic computational model of the joint and relevant soft tissues.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.