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

SBIR 第二阶段：用于外科手术和医疗机器人的模块化和可重构电磁导航系统

• 批准号: 2222580
• 负责人: Lev Koyrakh
• 金额: $ 97.38万
• 依托单位: RADWAVE TECHNOLOGIES INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2222580&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Modular; Reconfigurable

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.

该小型企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力是一种新型电磁导航系统，为需要准确性、效率和安全性的各种医疗程序提供变革性解决方案，其后续商业化将产生积极影响。该系统将能够在整个手术空间内跟踪医疗器械，提高准确性和可靠性，并减少患者和工作人员接触有害辐射的机会，同时与术中成像兼容。为在手术过程中按需创建和增加导航量，以及可靠地检测和减轻电磁干扰，该技术的更广泛的社会影响为美国的关键行业提供了一个灵活且高度可定制的平台，这些行业对美国的竞争力至关重要，包括生物医学、消费者、这个小型企业创新研究 (SBIR) 第二阶段项目将推进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多个复杂问题。每年在世界范围内进行其中包括心脏消融、瓣膜置换、支气管镜检查、骨科手术、癌症治疗等，随着机器人的使用不断增加，电磁导航系统在这些手术中被广泛使用，当医疗器械超出“界限”时，可以提供位置和方向的信息。目前可用的系统大多是在机器人手术广泛采用之前开发的，只能处理固定的导航体积，并且通常无法在整个手术空间中跟踪仪器，这可能需要使用额外的有害 X 射线辐射。庞大的场发生器与成像设备不兼容，并且只能对电磁干扰引起的位置失真进行有限的检测和校正。该项目将解决这些缺点，该电磁导航系统将能够强大地检测和减轻各种电磁干扰，从而实现程序时间。可调节的导航体积，将允许多个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差异化功能。该奖项反映了通过使用基金会的智力价值和更广泛的影响审查标准进行评估，NSF 的法定使命被认为值得支持。