SBIR Phase I: Novel Camera-Projector Device Leveraging Markerless Skin Registration and Projected Augmented Reality Software to Enable Navigation for Minimally Invasive Procedures

这个小型企业创新研究（SBIR）第一阶段项目是一个新颖的基于投影的平台，可以在手术过程中直接进行视觉映射。该项目旨在开发一种系统，直接将引导手术干预的图像真实的投影到患者身上。通过实现直接可视化和需要最少的耗材组件，该项目旨在解决阻碍采用当前手术标测平台的可用性和成本障碍。该产品针对脊柱腰椎手术市场，每年在美国进行近20万例手术。脊柱手术需要高水平的准确性，不准确的干预导致再手术率高达16%，再入院的直接和间接成本近150亿美元，患者预后较差。该小企业创新研究（SBIR）第一阶段项目旨在开发和验证一种新型的、基于投影的手术导航平台。该系统利用三维传感器来非侵入性地定向到每个患者，并将视觉解剖参考和引导投射到他们的皮肤表面上，从而真实的帮助外科医生。该项目将开发和验证硬件和软件，以重复和可靠地检测和对准患者的放射图像。 它还将开发和验证所需的核心算法，以确保所需的准确性和系统性能适合手术使用。原型将在台式体模上进行测试，并将其性能与腰椎手术所需的行业标准精度进行比较。该奖项反映了NSF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。

This Small Business Innovation Research (SBIR) Phase I project is a novel projection-based platform, enabling direct visual mapping during surgical procedures. The project aims to develop a system that directly projects images that guide surgical intervention in real time onto the patient. By enabling direct visualization and by requiring minimal consumable components, the project aims to address usability and cost barriers that hinder adoption of current surgical mapping platforms. This product targets the spinal lumbar surgical market accounting for nearly 200,000 U.S. procedures each year. Spinal surgery requires high levels of accuracy, with inaccurate interventions resulting in reoperation rates of up to 16%, and readmissions costing nearly $15 billion in both direct and indirect costs, as well as poorer patient outcomes. This Small Business Innovation Research (SBIR) Phase I project aims to develop and validate a novel, projection-based, surgical navigation platform. The system utilizes three dimensional sensors to non-invasively orient to each individual patient and project visual anatomical references and guidance onto their skin surface, aiding surgeons in real time. This project will develop and validate the hardware and software to repeatably and reliably detect and align radiological images onto patients. It will also develop and validate the core algorithms needed to ensure the required accuracy and system performance suitable for surgical use. The prototype will be tested on bench-top phantoms and its performance compared to the defined industry-standard accuracy measures required for lumbar spinal surgical procedures.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.