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.

项目总结