Bio-Effects of Ultra-High MRI Gradient Slew Rates

描述（由申请人提供）：本申请代表了II期STTR项目的竞争性续期请求，在该项目中，我们构建了一个用于磁共振成像的超快速梯度系统。该新系统的操作基于神经系统对非常短的暴露于变化的磁场相对不敏感的原理。因此，我们在临床试验中表明，磁转换率（即，每次梯度变化）可以比目前临床MRI扫描仪中可用的速度快1,000倍，并且提供高10倍的磁梯度，而没有痛苦的刺激。此次竞争性更新的目的是将该技术提升到FDA批准的水平。基于MRI物理学的既定原则，新技术允许的更高梯度强度和更短脉冲序列将对临床和研究系统的用户产生多种有意义的益处，包括总体采集时间缩短、声学噪声减少以及消除受试者运动引起的伪影。为该项目组建的多学科团队包括MRI物理学家、儿科和普通放射科医生、神经科学家、脉冲功率技术专家、医疗资本设备企业家以及活跃在该领域的潜在战略合作伙伴的技术代表。该团队在过去五年中合作无间，取得了重大成就，并在NIH SBIR计划的帮助下合作推出了四种医疗产品。该项目中要完成的重要任务包括使系统适应7特斯拉动物MRI扫描仪和临床3特斯拉系统、死后人体组织和移动脊椎动物的可视化、FDA规定的神经刺激和声学噪声的人体试验以及体内人脑的高分辨率纤维束成像和功能性MRI。从商业角度来看，将该产品配置为现有MRI系统的替代升级，对于几家公司来说是一个非常成功的财务策略，其中一家公司已承诺协助我们进行这一努力。对该国的潜在好处包括降低医疗保健成本（由于减少每位患者的扫描时间），增加科学知识和诊断信心，因为我们检查神经系统的较小特征，先进医疗产品的出口潜力，以及改善患者舒适度（因为我们减少了噪音和儿科和成人受试者的镇静需求）。 公共卫生相关性：对国家的潜在好处包括降低医疗保健成本（由于减少每位患者的扫描次数），增加科学知识和诊断信心，因为我们检查神经系统的较小特征，先进医疗产品的出口潜力，以及改善患者舒适度（因为我们减少了噪音和儿科和成人受试者的镇静需求）。

DESCRIPTION (provided by applicant): This application represents a competing renewal request for a Phase II STTR project, in which we constructed an ultra-fast gradient system for magnetic resonance imaging. Operation of the novel system is based upon the principle that the nervous system is relatively insensitive to very short exposures to changing magnetic fields. As a result, we are showing in clinical trials that magnetic slew rates (i.e., changes in gradients per time) can be 1,000 times faster than are currently available in clinical MRI scanners, and deliver magnetic gradients 10 times higher, without painful stimulation. The purpose of this competing renewal is to take the technology to the level of FDA approval. Based on well-established principles of MRI physics, it stands to reason that the increased gradient strength and shorter pulse sequences permitted by the new technology will have multiple meaningful benefits to users of clinical and research systems, including overall decreased acquisition time, reduction in acoustic noise, and elimination of artifacts due to subject motion. The multidisciplinary team assembled for this project includes MRI physicists, pediatric and general radiologists, and neuroscientists, experts in pulsed power technology, medical capital equipment entrepreneurs, and committed technical representatives of potential strategic partners active in this field. The team has worked well together over the past five years to achieve significant achievements, and has collaborated in the past to launch four medical products with the aid of the NIH SBIR program. Milestones to be accomplished in this project include adaptation of the system to a 7-Tesla animal MRI scanner and a clinical 3-Tesla system, visualization of post-mortem human tissues and moving vertebrate animals, FDA-mandated human trials of nervous stimulation and acoustic noise, and high- resolution tractography and functional MRI of the human brain in vivo. From a commercial point of view, configuring the product as a replacement upgrade to existing MRI systems has been a very successful financial strategy for several companies, one of which has committed to assisting us in this effort. Potential benefits to the country include health-care cost reduction (as a result of reduced scan-times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects). PUBLIC HEALTH RELEVANCE: Potential benefits to the country include health-care cost reduction (as a result of reduced scan- times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects).