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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是一种新型的电磁导航系统，为要求精度、效率和安全性的各种医疗程序提供了变革性的解决方案。这一能力的结果及其随后的商业化将对世界各地数百万患者的医疗程序结果产生积极影响。该系统将能够在整个程序空间内跟踪医疗器械，提高准确性和可靠性，减少患者和工作人员暴露在有害辐射中，同时与术中成像兼容。该设备将允许在程序期间根据需要创建和增加导航量，以及可靠地检测和减轻电磁干扰。这项技术的更广泛的社会影响为生物医学、消费者、工业和国防等对美国竞争力至关重要的关键行业提供了一个灵活且高度可定制的平台。这个小型企业创新研究(SBIR)第二阶段项目将推动一种新的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。全世界每年进行数以百万计的微创医疗手术，包括心脏消融、瓣膜置换、支气管镜检查、矫形手术、癌症治疗等，所有这些都伴随着越来越多的机器人使用。电磁导航系统被广泛应用于这些程序中，当医疗器械离开“视线”时，电磁导航系统提供位置和方向信息。目前可用的系统大多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量，而且往往无法在整个手术空间跟踪仪器，这可能需要使用额外的有害X射线辐射。目前的工具使用与成像设备不兼容的笨重的场发生器，并且仅提供有限的电磁干扰引起的位置失真的检测和校正。这个项目将解决这些缺点。电磁导航系统将对各种电磁干扰具有强大的检测和缓解能力，将实现程序时间可调的导航量，将允许多传感器的高位置采样率，并将与术中透视和计算机断层扫描(CT)成像兼容，从而实现商业化所需的关键区别功能。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 Innovation Research (SBIR) Phase II project is a novel electromagnetic navigation system offering 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 millions of patients worldwide. The system will enable tracking medical instruments over the full procedure space, improving accuracy and reliability, and reducing patients and staff exposure to harmful radiation while being compatible with the intraoperative imaging. The device will allow for the creation and augmentation of navigation volumes on demand during procedures as well as reliable detection and mitigation of electromagnetic interference. The broader societal impacts of the technology offer a flexible and highly customizable platform across key industry sectors important to the United States competitiveness including biomedical, consumer, industry, and defense. This Small Business Innovation Research (SBIR) Phase II project will advance the development of a new electromagnetic navigation system that requires the solution of several complex problems involving mathematics, computer science and electrical engineering. Millions of minimally invasive medical procedures are performed annually worldwide which include cardiac ablations, valve replacements, bronchoscopies, orthopedic procedures, cancer treatments, etc., all 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, mostly 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. Current tools use bulky field generators incompatible with imaging equipment and provide only limited detection and correction of electromagnetic interference-induced location distortion. This project will address these shortcomings. The electromagnetic navigation system which will have robust detection and mitigation of various electromagnetic interferences, will enable procedure-time adjustable navigation volumes, will allow high location sampling rates with multiple sensors, and will be compatible with intraoperative fluoroscopy and computed tomography (CT) imaging, allowing for key differentiating features required for commercialization.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.