Transvaginal Probe for Fetal Magnetocardiography

经阴道胎儿心磁图探头

• 批准号: 8058860
• 负责人: DOUGLAS N PAULSON
• 金额: $ 41.96万
• 依托单位: TRISTAN TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8058860
• 关键词: Address; Algorithms; Anatomy; Animal Testing; Animals; Arrhythmia; Brain; Cardiac; Cardiology; Cephalic; Clinic; Clinical; Data; Data Analyses; Detection; Development; Diagnostic; Disease; Early Diagnosis; Echocardiography; Electromagnetics; Environment; Equipment; Evaluation; Failure; Fetal Heart; Fetal Heart Rate; Fetus; Future; Gestational Age; Goals; Heart Diseases; Heart failure; Hereditary Disease; Human; Image; Knowledge; Labor Presentation; Lead; Life; Light; Magnetism; Magnetoencephalography; Measurement; Measures; Mechanics; Methods; Modeling; Monitor; Noise; Obesity; Patients; Pattern; Phase; Pregnancy; Prenatal care; Procedures; Reporting; Resolution; Risk; Scalp structure; Scientific Advances and Accomplishments; Series; Sheep; Signal Transduction; Simulate; Staging; Surface; System; Technology; Testing; Third Pregnancy Trimester; Transvaginal Ultrasound; Uterus; Vagina; Work; base; congenital heart disorder; cryogenics; design; design and construction; fetal; heart rhythm; high risk; improved; instrument; light weight; magnetic field; magnetoencephalogram; millimeter; minimally invasive; operation; pregnant; programs; prototype; safety testing; sensor; software systems; tool; trend; vector

DESCRIPTION (provided by applicant): Currently the detection of fetal magnetocardiogram (fMCG) is not possible at gestational ages earlier than 15 weeks, is unreliable at gestations less than 20-24 weeks, and is often difficult in obese patients even in the last trimester. This presents a series problem in the assessment of fetal heart conditions in patients with high- risk cardiac conditions in specific, and in prenatal care management in general. Transvaginal approach for fetal echocardiography has enhanced fetal imaging by allowing better resolution of extremely small fetal anatomy at close range down to about 13 weeks, but cannot precisely measure fetal heart rhythm and conduction disorders. To answer this challenge, pioneering work on fMCG has demonstrated the unique capabilities of SQUID-based fetal MCG system, including QRS and QT interval measurements, accurate beat- to-beat analysis, precise arrhythmia recording, and detailed fetal heart rate trend analysis. The objective of proposal is to develop a transvaginal SQUID fMCG system for direct recording of fetal cardiac activities at gestational ages younger 15 weeks, and in addition fetal brain electromagnetic activity. This will facilitate early detections of intrauterine clinical condition of fetuses with life-threatening arrhythmias, acquired heart failure, and structural congenital heart disease. Unlike the conventional fetal MCG system, which is bulky and requires to be installed in a heavy and costly magnetic shielded room, the new system will be designed to be compact and light, suitable for use in clinical settings. In this Phase II work we have identified major technical challenges, and will address them systematically to pave way for smooth transition to human testing in Phase III and to future clinical operations. The Phase I instrument will be modified to incorporate vector measurement and noise cancellation channels. The animal tests will be conducted to demonstrate the feasibility of the improved Phase I instrument in live objects. In data analysis new noise reduction algorithm will be integrated and tested. Results of these studies will guide the design and construction of light weight magnetic shielding that is easily adaptive to OBGYN clinics; vector sensor probe with reference array that can accommodate development of fetus at different pregnancy stages; safe and comfortable patient chair and probe gantry to streamline test procedures. A series of tests will be carried out to access risk level in simulated mechanical and cryogenic failures of the probe. Successful completion of this program will lead to the first-ever diagnostic tool for fetal cardiology that is capable of providing accurate recording from early pregnancy stages. It offers the significant ability to identify fetal arrhythmias and other cardiac disorders. In addition, it will greatly advance scientific knowledge on both fetal heart and brain development, which can lead to better prenatal care and potential treatments for genetic disorders. 1 PUBLIC HEALTH RELEVANCE: This proposal aims to develop a compact, noninvasive transvaginal SQUID-based magnetocardiography (fMCG) system for unique early monitoring of fetal heart rhythm conditions. The transvaginal placement is the most effective minimally invasive method for optimizing the signal-to-noise ratio in obese patients and in early pregnancy, as has been demonstrated with transvaginal ultrasound. The new instrument will be a world's first in its capability to reliably characterize the conduction patterns and intrauterine clinical condition of fetuses with life-threatening arrhythmias, acquired heart failure, and structural congenital heart disease. In addition, its impact on the field of fetal Magnetoencephalography (fMEG) could be even greater since intrauterine evaluation of human fetal brain function has so far been impossible. 1

描述（由申请人提供）：目前，在妊娠年龄不足15周的胎龄检测到胎儿心脏心动图（FMCG）是不可能的，在妊娠小于20-24周时，胎儿的检测是不可靠的，即使在上个三个月中，肥胖患者也常常很难。这在评估特异性心脏病患者的胎儿心脏病评估中提出了一个问题，总体上和产前护理管理中的患者。胎儿超声心动图的经阴道方法通过允许在近距到13周的近范围内更好地分辨出极小的胎儿解剖结构，从而增强了胎儿成像，但不能精确地测量胎儿心律和传导障碍。为了应对这一挑战，FMCG上的开创性工作证明了基于鱿鱼的胎儿MCG系统的独特功能，包括QRS和QT间隔测量，准确的Beat-Beat-beat分析，精确的心律不齐记录以及详细的胎儿心率趋势分析。 建议的目的是开发一个经阴道的鱿鱼FMCG系统，用于在15周的胎龄直接记录胎儿心脏活动，此外，胎儿脑电磁活性。这将促进胎儿内临床状况的早期检测，并具有威胁生命的心律不齐，心力衰竭和结构性先天性心脏病。与传统的胎儿MCG系统不同，该系统笨重，需要安装在重型且昂贵的磁性屏蔽室中，新系统将设计为紧凑和轻巧，适合在临床环境中使用。 在这第二阶段的工作中，我们确定了主要的技术挑战，并将系统地解决这些挑战，以铺平道路，以平稳过渡到第三阶段和将来的临床操作。 I阶段仪器将进行修改以结合矢量测量和降噪通道。将进行动物测试，以证明活物体中I期仪器改进的可行性。在数据分析中，将集成和测试新的降噪算法。这些研究的结果将指导轻质磁性屏蔽的设计和构建，这些屏蔽很容易适应OBGYN诊所。带有参考阵列的矢量传感器探测器可以在不同的怀孕阶段适应胎儿的发展；安全舒适的病人椅子和探测龙门，以简化测试程序。将进行一系列测试以在探针的模拟机械和低温故障中获取风险水平。 该计划的成功完成将导致有史以来第一个用于胎儿心脏病学的诊断工具，该工具能够从早期妊娠阶段提供准确的记录。它提供了鉴定胎儿心律不齐和其他心脏疾病的重要能力。此外，它将大大提高胎儿心脏和大脑发育的科学知识，这可以使产前护理和潜在的遗传疾病治疗。 1 公共卫生相关性：该提案旨在开发紧凑的，无创的经阴道鱿鱼心电图（FMCG）系统，以实现胎儿心律条件的独特早期监测。经阴道放置是优化肥胖患者和怀孕早期信噪比的最有效的最小侵入性方法，正如经阴道超声证明的那样。该新仪器将是世界上第一个能力，可以可靠地表征胎儿的传导模式和胎儿内临床状况，并具有威胁生命的心律不齐，心力衰竭和结构性先天性心脏病。此外，由于迄今为止对人类胎儿脑功能的评估是不可能的，因此它对胎儿磁脑摄影（FMEG）（FMEG）的影响可能更大。 1