Biomagnetic Liver Susceptometry based on Piezoelectric Magnetic Sensors

铁超载影响了美国和世界各地许多人的生活。肝脏铁 浓度提供了身体铁水平的直接指标。在各种非侵入性 方法，生物磁肝血流测量（BLS）已被证明是提供唯一的 测定肝脏铁储备的直接方法。然而，BLS需要成本高昂的 （~ 100万）和复杂（~ 4 K，液氦）SQUID磁强计，这限制了 临床应用该技术。该SBIR项目的目标是开发一个 低成本、紧凑尺寸和便携式室温生物磁肝血流测量法 (PM BLS）基于压电生物磁传感器， 简单、无创、定量评估肝脏铁浓度。拟议 努力探讨了独特的机会所提供的最新进展，压电磁 在强直流电存在下表现出超高交流磁灵敏度的传感器 宾夕法尼亚州立大学张教授实验室的磁性背景和突破 在成功演示的性能的压电磁大学（PSU） 使用肝脏模型的传感器。具体来说，Nascent Devices LLC建议开发一种 压电磁（PM）传感器磁强计，并进行直接比较， 加州大学旧金山分校贝尼奥夫儿童医院的SQUID BLS。在目标1中，我们 开发一种紧凑的PM传感器重力仪，一阶梯度仪配置， 准备进行临床研究。在目标2中，我们将使用Liver校准PM传感器 不同铁浓度的模拟结果，并与计算机模拟结果进行了比较。 在目标3中，直接比较一阶PM生物磁阻抗测量法与 SQUID BLS对人类受试者的影响。现有的测试结果显示，我们的PM BLS将具有 在评估肝脏铁浓度（LIC）时，与SQUID BLS的灵敏度相同或更好， 更接近肝脏的距离，在更高的扫描速率下改善SNR，以及更大的灵活性 成本低得多（<5，000美元）的移动性。 在这个计划中将要开发的PM BLS技术是“常规”的， “破坏性”。它是常规的，因为这项技术将采用SQUID的原理， 基于BLS，已被证明是有效的量化LIC。这是破坏性的 因为这项技术可以带来成本和尺寸上的突破，这将导致 便携式医生诊所或患者床边BLS设备的开发 未来SBIR第二阶段和第三阶段的应用。

Iron overload affects life of many people in the US and around the world. Liver iron concentration provides a direct indicator of body iron level. Among various noninvasive methods, Biomagnetic liver susceptometry (BLS) has been proven to provide the only direct means of determining hepatic iron stores. However, BLS requires cost-prohibitive (~ 1 million) and complex (~ 4 K, liquid helium) SQUID magnetometer, which limits the clinical adoption of this technology. The objective of this SBIR project is to develop a low-cost, compact-size, and portable room temperature biomagnetic liver susceptometry (PM BLS) based on piezoelectric biomagnetic sensor for general clinical use to quickly, easily, noninvasively, and quantitatively assess liver iron concentration. The proposed effort explores the unique opportunity afforded by recent advances in piezo-magnetic sensors that exhibit ultra-high AC magnetic sensitivity in the presence of strong DC magnetic background and breakthrough at Prof. Zhang’s laboratory of Penn State University (PSU) in successful demonstration of the performance of piezo-magnetic sensor using liver phantoms. Specifically, Nascent Devices LLC proposes to develop a piezoelectric magnetic (PM) sensor susceptometer and carry out a direct comparison with the SQUID BLS at UCSF Benioff Children’s Hospital Oakland, CA. In Aim 1, we will develop a compact PM sensor susceptometry, a first order gradiometer configuration and ready for clinical study. In Aim 2, we will carry out calibration of the PM sensors with Liver phantoms of different iron concentrations and compared with computer simulation results. In Aim 3, direct comparison of the first order PM biomagnetic susceptometry with the SQUID BLS on human subjects. Available test results reveal that our PM BLS will have equal or better sensitivity to SQUID BLS in assessing liver iron concentration (LIC) due to closer distance to the liver, improved SNR at higher scan rate, and greater flexibility and mobility with much lower cost (< $5,000). The PM BLS technology to be developed in this program is both “conventional” and “disruptive”. It is conventional because this technology will adopt the principle of SQUID- based BLS which has been proven to be effective in quantifying LIC. It is disruptive because the technology can lead to breakthroughs in cost and size, which would lead to the development of a portable physician clinics’ or patient bed-side BLS device in the future SBIR Phase II and Phase III applications.