Bio-Effects of Ultra-High MRI Gradient Slew Rates

描述（由申请人提供）：本申请代表了STTR二期项目的竞争性更新请求，我们在该项目中构建了一个超快速梯度磁共振成像系统。这种新系统的运作是基于神经系统对极短的磁场变化相对不敏感的原理。因此，我们在临床试验中显示，磁转率（即每次梯度的变化）可以比目前临床MRI扫描仪快1000倍，并提供高10倍的磁梯度，而不会产生痛苦的刺激。这种竞争性更新的目的是将技术提升到FDA批准的水平。基于公认的MRI物理原理，新技术允许的梯度强度增加和脉冲序列缩短将为临床和研究系统的用户带来多重有意义的好处，包括总体减少采集时间，减少噪声，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忠实技术代表。该团队在过去五年中合作良好，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。该项目要完成的里程碑包括将该系统适应于7特斯拉动物MRI扫描仪和临床3特斯拉系统，对死后人体组织和活动的脊椎动物进行可视化，fda规定的神经刺激和声学噪声人体试验，以及高分辨率神经束造影和活体人脑功能MRI。从商业角度来看，配置该产品作为现有MRI系统的替代升级对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项工作。对国家的潜在好处包括降低医疗保健成本（由于每位患者的扫描次数减少），增加科学知识和诊断信心，因为我们检查了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对儿童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).