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

这个小企业技术转移计划(STTR)第一阶段项目的更广泛的影响/商业潜力是与以下相关的整形外科护理的显著改善：(1)通过显著降低成本，广泛扩大患者获得改进的程序的机会；(2)通过针对患者的手术干预，改善结果。尽管骨科医生、医院和患者对先进技术解决方案有需求，但现有的手术导航先进技术无法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。尽管临床结果优越，但目前在美国进行的关节置换手术中，只有不到15%使用先进技术，这为满足未得到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。这项拟议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。这个小企业技术转移计划(STTR)第一阶段项目专注于开发尖端、低成本的手术导航，以帮助整形外科医生为所有关节置换患者实现精确、个性化的植入物适配和放置。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。它们增加了手术过程的时间和复杂性，需要额外和更大的切口来容纳用于将跟踪器固定到患者骨骼上的侵入性针头。拟议的系统利用先进的3D扫描绘制患者解剖图，并采用专有的雷达跟踪技术来帮助外科医生为每个患者理想地安装和放置植入物。这个第一阶段的项目旨在实现以下技术目标：(1)验证高分辨率雷达跟踪的准确性，(2)实施3D扫描以将患者的成像数据注册到他们的解剖结构，以及(3)验证手术计划系统，以使用关节和相关软组织的解剖计算模型为每个患者个性化手术。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.