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，可以在手术过程中实现直接的可视化映射。该项目旨在开发一种系统，该系统可以直接将实时指导手术干预的图像投射到患者身上。通过实现直接可视化和对可消耗组件的需求最小化，该项目旨在解决阻碍当前外科测绘平台采用的可用性和成本障碍。该产品针对的是腰椎手术市场，在美国每年有近20万例手术。脊柱手术需要很高的准确性，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接近150亿美元，患者的预后也较差。这项小企业创新研究（SBIR）第一阶段项目旨在开发和验证一种新颖的、基于投影的手术导航平台。该系统利用三维传感器非侵入性地定位每个患者，并将视觉解剖参考和指导投射到他们的皮肤表面，实时帮助外科医生。该项目将开发和验证硬件和软件，以重复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适合手术使用的系统性能。该样机将在工作台上进行测试，并将其性能与腰椎外科手术所需的工业标准准确度进行比较。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。

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.