STTR Phase I: Optical Sensor for Guiding Medical Needles

如果成功，小型企业技术转移研究(STTR)第一阶段项目的更广泛影响/商业潜力将使开发出有史以来最小的拉曼光谱光纤探头成为可能。更小的拉曼探头的优化将改进广泛的临床应用，如心脏血管造影过程中的冠状动脉斑块诊断。此外，这项拟议的技术代表了一种基于非侵入性光电子传感技术的新型智能手术工具。通过将智能算法集成到各种手术工具中，该团队预计将提高患者的安全性，同时降低因手术并发症而导致的医疗成本。最后，生物光子学技术的存在可以改善患者护理和临床结果。然而，它们中的许多都很昂贵，并不能降低整体医疗成本。由于医疗费用目前是国家预算的优先事项，开发能够在这两个方面提供改善的生物光子学技术是优先事项。预计一种低成本、易于使用、基于光学光谱学的针头放置技术不仅将提高各种外科手术的安全性，还将通过减少由于针头和器械错位而导致昂贵的医疗并发症的可能性来降低总体医疗成本。拟议的项目将开发一种微型拉曼光谱(RS)探头，可以安装在硬膜外针头中。这将是迄今为止研制出的最小的遥感探测器。在美国，每年有4500万例医疗手术依靠盲人或半盲人将针头插入组织。并发症包括使人虚弱的头痛、脊髓损伤、感染、出血、器官损伤和无效的手术。这些并发症每年给美国医疗体系造成的成本超过200亿美元。每年放置1300万个硬膜外针头，12-27亿美元的即时医疗费用加上额外的持续医疗费用用于针头错位。体外组织学研究表明，RS能分化出从皮肤到脊髓的各个组织层。在STTR第一阶段期间，该团队将开发一种微型拉曼探头，可以安装在硬膜外针头(17号托希针)中。还将开发一种便携式临床原型设备。该装置将通过在MGH动物设施进行的活体动物研究来验证。该系统的性能将与目前使用的阻力损失(LOR)硬膜外插入法进行比较。

The broader impact/commercial potential of this Small Business Technology Transfer Research (STTR) Phase I project will be, if successful, enabling the development of the smallest Raman spectroscopy-capable fiber probe ever developed. The optimization of a smaller Raman-capable probe will improve a broad range of clinical applications such as coronary artery plaque diagnosis during cardiac angiography procedures. In addition, the proposed technology represents a new class of 'intelligent' surgical tools based on non-invasive photonics sensing technology. By integrating intelligent algorithms into a variety of surgical tools, the team expects to improve patient safety, while reducing medical costs resulting from procedure complications. Finally, biophotonics technologies exist which could improve patient care and clinical outcomes. However, many of them are expensive and do not reduce overall medical costs. As medical costs are currently a national budget priority, the development of biophotonics technologies, that can provide improvements on both fronts, is a priority. It is expected that a low cost, easy to use, optical spectroscopy-based needle placement technology will not only improve the safety of a variety of surgical procedures but also reduce overall medical costs by decreasing the probability of expensive medical complications due to needle and instrument misplacement. The proposed project will develop a miniature Raman spectroscopy (RS) probe which can be incorporated into epidural needles. This will be the smallest RS probe ever developed. Forty-five million medical procedures take place in the U.S. each year which rely on the blind or semi-blind insertion of needles into tissue. Complications include debilitating headaches, spinal cord injury, infection, bleeding, damage to organs, and ineffective procedures. The cost to the U.S. healthcare system from these complications exceeds $20 billion annually. Each year, 13 million epidural needles are placed and $1.2-$2.7 billion in immediate healthcare costs plus additional ongoing healthcare costs are spent for needle misplacement. From ex-vivo tissue study, we showed that RS can differentiate every tissue layers from skin to spinal cord. During the STTR phase I period, the team will develop a miniature Raman probe which can be incorporated into epidural needles (17-gauge Tuohy needle). A portable clinical prototype device will also be developed. The device will be validated by a live animal study in the MGH animal facility. The performance of the system will be compared to the currently used loss-of-resistance (LOR) epidural insertion method.