Bio-Effects of Ultra-High MRI Gradient Slew Rates

描述(由申请人提供)：本申请代表了一项针对第二阶段STTR项目的竞争性续签请求，在该项目中，我们构建了一个用于磁共振成像的超快梯度系统。该新系统的工作原理是基于神经系统对非常短的变化磁场暴露相对不敏感的原理。因此，我们在临床试验中表明，磁转换速率(即每次梯度的变化)可以比目前临床MRI扫描仪的速度快1000倍，并在没有痛苦刺激的情况下提供10倍高的磁梯度。这一竞争性更新的目的是将该技术带到FDA批准的水平。根据公认的磁共振成像物理学原理，理所当然的是，新技术允许的更高的梯度强度和更短的脉冲序列将对临床和研究系统的用户有多种有意义的好处，包括总体上减少采集时间，减少噪音，以及消除因受试者运动而产生的伪像。为该项目组建的多学科团队包括核磁共振物理学家、儿科和普通放射科医生、神经学家、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坚定技术代表。在过去的五年里，该团队通力合作，取得了显著的成就，并在过去的合作中，在NIH SBIR计划的帮助下推出了四种医疗产品。该项目将完成的里程碑包括使该系统适应7-特斯拉动物核磁共振扫描仪和临床3-特斯拉系统，对人体组织和移动的脊椎动物进行解剖后的可视化，FDA授权的神经刺激和声学噪声的人体试验，以及人体体内的高分辨率脑束成像和功能核磁共振。从商业角度来看，将该产品配置为现有MRI系统的替代升级已经是几家公司非常成功的财务战略，其中一家公司已承诺协助我们进行这一努力。对国家的潜在好处包括降低医疗保健成本(因为减少了每个患者的扫描次数)，增加了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，以及患者舒适度的改善(因为我们减少了噪音，减少了儿童和成人受试者对镇静的需求)。

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).