Photonic Magnetometer-based Biomagnetic Imaging System

描述（由申请人提供）：除了MRI和一定程度上的MEG之外，由于低温和磁屏蔽所带来的高成本和要求，生物磁成像系统仅限于用作实验室研究工具。然而，生物磁成像工具已经证明了它们在临床重要问题诊断中的潜力。例如，心磁图（MCG）系统可用于：（a）评估危及生命的心律失常的风险;（B）检测和表征缺血性心脏病，（c）非侵入性地定位心脏激活，例如引起心律失常的区域、起搏导管和心脏诱发场或缺血电流，以及（d）研究胎儿心脏功能。为了满足能够在无屏蔽临床环境中运行的非低温多通道磁成像系统的需求，物理光学公司（POC）提出开发基于光子磁强计的生物磁成像（PMBI）系统。关键的创新是一个高性能的光子磁力计（PM），形成了成像传感器阵列（伊萨）的构建块。伊萨由数百个PM组成，嵌入在包裹患者腹部的背心中，能够对胸部的背部和侧面以及前部进行成像，这可以显着提高异常心脏功能的检测和定位。此外，室温传感器的使用消除了对昂贵的、笨重的低温的需要，使得能够实现更通用的和商业上可行的成像系统。消除通常将低温传感器与身体表面分开的15至20 mm的隔热层，将信噪比提高了10倍。噪声消除算法与高阶梯度测量相结合，使PMBI系统能够在非屏蔽环境中运行，从而消除了对磁屏蔽室的需求，磁屏蔽室构成了当前商业系统拥有成本（1 - 200万美元）的很大一部分。PMBI系统的成本（约1万美元）将降低几个数量级，从而能够广泛用于临床和护理点应用。第一阶段将在实验室测试中展示PMBI系统的概念验证原型。第一阶段有限性能试验板原型将由现成的低成本组件组装而成。可行性将通过预测原型性能的实验验证来证明，并将概述开发定制的、功能齐全的第二阶段原型的路径，该原型满足最终PMBI系统的目标性能目标。PMBI的生产和商业化工艺将在第II阶段开发和测试。 公共卫生相关性：在许多发达国家，心脏病是死亡的主要原因。心磁图（MCG）是一种安全、无创、被动的心脏磁场成像方法，已被证明是缺血性心脏病等心脏疾病的准确风险指标。不幸的是，由于低温冷却和磁屏蔽要求所强加的数百万美元的价格标签，MCG系统几乎完全没有临床实践。Physical Optics Corporation提出开发一种低成本、非低温生物磁成像系统，适用于无屏蔽的临床和床旁应用。

DESCRIPTION (provided by applicant): With the exception of MRI, and to a certain extent MEG, biomagnetic imaging systems have been limited to use as laboratory research tools, due to the high cost and demands imposed by cryogenics and magnetic shielding. Nevertheless, biomagnetic imaging tools have demonstrated their potential for diagnosis in clinically important problems. For example, magnetocardiography (MCG) systems can be used to: (a) assess risk of life- threatening arrhythmias; (b) detect and characterize ischemic heart disease, (c) noninvasively localize cardiac activation, such as arrhythmia-causing regions, a pacing catheter and cardiac evoked field, or ischemic currents, and (d) study fetal heart function. To address the need for a noncryogenic multichannel magnetic imaging system capable of operating in an unshielded clinical environment, Physical Optics Corporation (POC) proposes to develop a Photonic Magnetometer-based Biomagnetic Imaging (PMBI) system. The key innovation is a high-performance photonic magnetometer (PM) that forms the building block of an imaging sensor array (ISA). The ISA consists of an array of hundreds of PMs, embedded in a vest that wraps around the patient's abdomen, enabling imaging of the back and side of the chest, as well as the front, which can significantly improve the detection and localization of abnormal cardiac function. In addition, the use of room- temperature sensors eliminates the need for costly, bulky cryogenics, enabling a more versatile and commercially viable imaging system. Eliminating 15 to 20 mm of thermal insulation that normally separates cryogenic sensors from the body surface improves the signal-to-noise ratio by a factor of up to 10. Noise cancellation algorithms, combined with high-order gradiometry, allow the PMBI system to operate in an unshielded environment, eliminating the need for magnetically shielded rooms that form a significant fraction of the cost of ownership ($1-2M) of current commercial systems. The cost of the PMBI system (~$10k) will be several orders of magnitude lower, enabling widespread use in clinical and point-of-care applications. Phase I will culminate in a demonstration of a proof-of-concept prototype of the PMBI system in laboratory testing. The Phase I limited-performance breadboard prototype will be assembled from readily available, low-cost components. Feasibility will be demonstrated through experimental verification of predicted prototype performance, and a path will be outlined for development of a custom-built, fully functional Phase II prototype that meets targeted performance goals for the final PMBI system. Processes for manufacturing and commercializing PMBI will be developed and tested in Phase II. PUBLIC HEALTH RELEVANCE: In many developed nations, cardiac disease is the leading cause of death. Magnetocardiography (MCG) is a safe, noninvasive, passive method for imaging the magnetic fields generated by the heart, that have been demonstrated to be accurate risk indicators for cardiac disorders such as ischemic heart disease. Unfortunately, MCG systems are almost completely absent from clinical practice due to the million-dollar price tag imposed by cryogenic cooling and magnetic shielding requirements. Physical Optics Corporation proposes to develop a low-cost, noncryogenic biomagnetic imaging system suitable for unshielded clinical and point-of- care applications.