A scalable superconducting dual-shielded fetal magnetocardiography system

可扩展的超导双屏蔽胎儿心磁图系统

• 批准号: 10480398
• 负责人: William Goodman
• 金额: $ 88.84万
• 依托单位: APPLIED PHYSICS SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480398
• 关键词: Address; Arrhythmia; Attenuated; Beds; Benign; Cardiac; Cardiotocography; Certification; Claustrophobias; Computer software; Contracts; Data; Data Collection; Devices; Diagnosis; Echocardiography; Electrocardiogram; Electrophysiology (science); Environment; FDA approved; Fetal Heart; Fetus; Helium; Housing; Incidence; Laboratories; Lead; Life; Liquid substance; Magnetism; Maintenance; Manufacturer Name; Measurement; Measures; Medical Device; Metals; Methods; Noise; Optics; Patients; Performance; Persons; Phase; Physics; Pregnancy; Pregnant Women; Provider; Pump; Records; Research Personnel; Residual state; Resolution; Risk; Safety; Savings; Ships; Signal Transduction; Study Subject; Sudden Death; System; Temperature; Testing; Time; Unexplained fetal death; Wisconsin; base; commercialization; cost; cryogenics; design; design verification; ferrite; fetal; heart electrical activity; heart function; high risk; human subject; improved; improved outcome; innovation; instrument; instrumentation; magnetic field; medical schools; pregnant; prototype; scale up; screening; sensor; success; superconducting quantum interference device; usability

PROJECT SUMMARY There are 26,000 unexplained fetal deaths in the US and over 4 million worldwide annually. Fetal cardiac arrythmia is a significant cause of fetal demise and is diagnosed in 1-3% pregnancies. While most occurrences are benign, serious arrhythmia can lead to life-threatening complications if undiagnosed or untreated. Echocardiography and cardiotocography have been widely used to assess fetal cardiac function; however, their use has not reduced the incidence of fetal sudden death. Fetal magnetocardiography (fMCG) records the magnetic fields generated by the electrical activity of the heart, enabling direct assessment of fetal heart electrophysiology. However, the only FDA-approved fMCG system uses expensive SQUID sensors and requires a dedicated magnetically shielded room (MSR) to achieve the necessary sensitivity to detect the fetal magnetic signal above environmental magnetic interference. Thus, the prohibitive expense and impracticality limits the use of a potentially life-saving device and there remains significant need for a sensitive device that is affordable and accessible to improve outcomes for fetal cardiac arrhythmias. Applied Physics Systems’ (APS) solution is an integrated fMCG system that uses the more affordable, optically pumped magnetometer sensors (OPMs), which are now as sensitive as SQUID sensors, with an innovative superconducting dual-shield. A laboratory prototype of an OPM-based fMCG with a person-sized ferromagnetic shield has already been developed and a human subject study demonstrated feasibility of an OPM-based fMCG system as sensitive and accurate as SQUID-based fMCG, but at a fraction of the cost. However, the shield in the laboratory prototype allowed higher noise in the fMCG recordings compared to SQUID in an MSR. This shielding is the remaining technical hurdle to reach commercialization. Superconducting shields have superior shielding compared to ferromagnetic shields and APS has 40 years of success in commercializing superconducting dual-shielding in rock magnetometer systems. Our preliminary data demonstrates proof of concept of improved OPM sensitivity within such a shielding system. Therefore, APS will build upon these studies to create a superconducting dual-shield system to reduce environmental noise, thus improving signal sensitivity and usability of the system through 3 aims. In Aim 1, we will scale up our superconducting dual-shield system to be person-sized and design the OPM sensor array and its associated software. We will demonstrate the shielding performance of our system matches or exceed that of a standard MSR and thermal performance of the superconducting system. In Aim 2, we will fully assemble the fMCG system with a patient conveyance system and confirm it meets electrical safety standards. In Aim 3, we will conduct human subject studies, first in non- pregnant subjects to confirm safety, then in pregnant subjects to confirm sensitivity and accuracy of our fMCG system compared to the FDA-approved SQUID-based fMCG system.

项目摘要 美国有26,000例未识别的胎儿死亡，全球超过400万。 Arrythmia是胎儿灭亡的重要原因，在大多数情况下诊断为1-3％ 如果没有诊断或未经治疗，则是良性的，严重的心律不齐会导致威胁生命的并发症。 超声心动图和心脏传播学已被广泛用于评估胎儿心脏功能。 使用尚未降低胎儿猝死的发生率。 由心脏的电活动产生的磁场，可以直接评估胎儿心脏 但是，电生理学。 专用的磁性屏蔽室（MSR），以达到必要的灵敏度来检测胎儿磁 信号高于环境磁干扰。 使用潜在的挽救生命设备，并且仍然非常需要负担得起的敏感设备 可访问以改善胎儿心律不齐的结果。 应用物理系统（APS）解决方案是一种集成的FMCG系统，它使用更实惠的， 光学泵送磁力计传感器（OPMS），它们对鱿鱼传感器很敏感，并具有 创新的超导双挡。 铁磁屏蔽已经开发出来，人类学科的研究表明 基于OPM的FMCG系统像基于鱿鱼的FMCG一样敏感且准确，但成本的一小部分。 但是，与鱿鱼相比 在MSR中，这种屏蔽是剩余的技术障碍 与铁磁屏蔽和APS相比，具有优越的屏蔽层在商业化方面有40年的成功 岩石磁力计系统中的双向磁杆。我们的前数据证明了 因此，在这种屏蔽系统中提高了OPM敏感性的概念。 创建一个超导双屏体系统以减少环境噪声，从而提高信号灵敏度 和系统的可用性在AIM 1中 设置人尺寸并设计OPM传感器阵列，并且是Ascived的软件。 我们的系统的性能匹配或授予标准MSR的性能以及 超导系统在AIM 2中 并确认它符合AIM 3中的电标准，我们将进行人类学科研究，首先 怀孕的受试者确认安全，然后在怀孕受试者中确认我们的FMCG的敏感性和准确性 与基于FDA批准的FMCG系统相比，系统。