SBIR Phase I: Modular And Reconfigurable Electromagnetic Navigation System For Surgical Interventions And Medical Robotics

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一种新型电磁导航系统，为要求准确性、效率和安全性的广泛医疗程序提供变革性解决方案。这种能力的结果及其随后的商业化将对全世界患者的医疗程序结果产生积极影响。该系统将能够在整个过程中跟踪医疗器械，提高准确性和可靠性，并减少患者和工作人员暴露于有害辐射，同时与术中成像兼容。它将在医疗过程中根据需要创建和增加导航容量。该系统将能够可靠地探测和减轻电磁干扰。该解决方案的商业和市场潜力是巨大的，基于对寻求新型电磁导航功能的行业代表的访谈。该技术的更广泛的社会影响提供了灵活和高度可定制的平台，跨越对美国竞争力至关重要的关键工业部门，包括生物医学、消费、工业和国防部门。这个小企业创新研究（SBIR）第一阶段项目将推进一种新型电磁导航系统的开发，该系统需要解决涉及数学、计算机科学和电气工程的几个复杂问题。全世界每年进行数百万例微创手术，包括心脏消融、瓣膜置换术、支气管镜检查、骨科手术、癌症治疗等。所有这些程序都在越来越多地使用机器人来处理。电磁导航系统在这些程序中广泛使用，当医疗器械不在“视线”中时，它可以提供位置和方向的知识。目前可用的系统是在广泛采用机器人手术之前开发的，只能处理固定的导航体积，并且通常无法在整个手术过程中跟踪仪器，这可能需要使用额外的有害x射线辐射。目前的系统使用笨重的磁场发生器，与成像设备不兼容，只能有限地检测和校正人体中由电磁干扰引起的位置失真。这个项目将解决这些缺点。它充分利用了微创和机器人市场领先公司的行业专业知识和需求验证，经验丰富的团队的效率和创新，以及公司开发的功能性电磁导航系统原型。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 I project is a novel electromagnetic navigation system that offers a transformative solution for a wide range of medical procedures that demand accuracy, efficiency, and safety. The result of this capability and its subsequent commercialization will positively affect the outcomes of medical procedures for patients worldwide. The system will enable tracking medical instruments over the full procedure space, improve accuracy and reliability, and reduce patient and staff exposure to harmful radiation while being compatible with the intraoperative imaging. It will create and augment navigation volumes on demand during the medical procedures. The system will enable reliable detection and mitigation of electromagnetic interference. The commercial and market potential of this solution is significant based on customer discovery interviews with industry representatives seeking novel electromagnetic navigation capabilities for minimally invasive and robotic medical procedures. The broader societal impacts of the technology offer flexible and highly customizable platforms across key industry sectors important to United States competitiveness including biomedical, consumer, industrial, and defense sectors. This Small Business Innovation Research (SBIR) Phase I project will advance the development of a new electromagnetic navigation system that requires solving several complex problems involving mathematics, computer science, and electrical engineering. Millions of minimally invasive procedures are performed annually worldwide which include cardiac ablations, valve replacements, bronchoscopies, orthopedic procedures, cancer treatments, etc. All of these procedures are being treated with increasing robot utilization. Electromagnetic navigation systems are widely used in these procedures providing knowledge of locations and orientations when medical instruments are out of the “line of sight”. Currently available systems, developed before the wide adoption of robotic surgeries, can handle only fixed navigation volumes and are often unable to track instruments throughout the full procedure space, which may require the use of additional harmful X-ray radiation. The current systems use bulky field generators incompatible with imaging equipment and provide only limited detection and correction of electromagnetic interference-induced location distortion in the body. This project will address these shortcomings. It leverages the industry expertise and demand validation by leading companies in the minimally invasive and robotics markets, the efficiency and innovation of an experienced team, and a functional electromagnetic navigation system prototype developed by the company.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.