Adult Optical Non-Invasive Brain Oxygenation Monitor

描述（由申请人提供）：需要一种用于成人患者的无创床旁监护仪，以连续测量脑氧合。近红外光谱（NIRS）是一种基于光学的技术，可以满足这种需求。然而，NIRS仪器尚未实现其最初预期的潜力，成为常规临床监测补充脉搏血氧饱和度。一个主要的挑战是开发一种光学探头和相应的算法，以解决成人近红外光谱应用中来自脑外组织（皮肤，头皮和头骨）的干扰问题。另一个关键问题是开发一种算法，该算法将能够绝对量化光学信号，以导出具有临床意义的定量变量或指标。我们的目标是通过开发一种近红外光谱监测仪来解决这些问题，该监测仪将确定成人患者的绝对脑血红蛋白氧饱和度。 在第一阶段，我们已经确定了一个最佳的成人近红外光谱探头配置，以尽量减少脑外干扰。我们定量地证明了脑外组织氧合干扰的影响是减少使用新的算法与实验使用猪模型，并与初步的人类成人研究。我们证明了我们的新算法可以在猪模型的全氧饱和度范围内以高精度确定绝对脑氧饱和度（SnO2）。 本SBIR II期提案的主要目标是：1）完善用于成人患者的NIRS监测器的设计。构建和测试改进的原型，并确定商业成人NIRS监测系统的制造前要求。2)验证我们的NIRS监测仪用于测量健康成人的绝对氧饱和度。

DESCRIPTION (provided by applicant): There is a need for a non-invasive bedside monitor for adult human patients to continuously measure brain oxygenation. Near-infrared spectroscopy (NIRS) is an optically based technique that could meet such demand. However, NIRS instruments have yet to achieve their initially expected potential of becoming routine clinical monitors complementary to pulse oximetry. One major challenge is to develop an optical probe and a corresponding algorithm to solve the problem of interference from extracerebral tissue (skin, scalp, and skull) in adult NIRS applications. Another critical issue is to develop an algorithm that will be able to absolutely quantify the optical signals to derive quantitative variables or indices that are of clinical significance. Our goal is to resolve these issues by developing an NIRS monitor that will determine absolute brain hemoglobin oxygen saturation on adult patients. In Phase I, we have determined an optimum adult NIRS probe configuration to minimize extracerebral interference. We quantitatively demonstrated that the effect of extracerebral tissue oxygenation interference is reduced using a novel algorithm with experiments using the pig model, and with a preliminary human adult study. We demonstrated that our novel algorithm could determine absolute brain oxygen saturation (SnO2) with a high degree of accuracy over a full range of oxygen saturation in the pig model. The primary objectives of this SBIR Phase II proposal are: 1) To refine the design of a NIRS monitor for use on adult human patients. To construct and test improved prototypes and to determine pre-manufacturing requirements of a commercial adult NIRS monitor system. 2) To validate our NIRS monitor for measuring absolute oxygen saturation in healthy human adults.