STTR Phase I: Optical Sensor for Guiding Medical Needles

这个小企业技术转让研究（STTR）第一阶段项目的更广泛的影响/商业潜力，如果成功的话，将使有史以来最小的拉曼光谱光纤探头的开发成为可能。更小的拉曼探头的优化将改善广泛的临床应用，例如心脏血管造影术过程中的冠状动脉斑块诊断。此外，所提出的技术代表了一类新的基于非侵入性光子传感技术的“智能”手术工具。通过将智能算法集成到各种手术工具中，该团队希望提高患者的安全性，同时降低手术并发症导致的医疗成本。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，其中许多是昂贵的，并没有降低整体医疗费用。由于医疗费用目前是国家预算的优先事项，因此开发可以在两个方面提供改进的生物光子技术是一个优先事项。预期低成本、易于使用、基于光谱的针放置技术将不仅提高各种外科手术的安全性，而且通过降低由于针和器械误放置而导致的昂贵医疗并发症的概率来降低总体医疗成本。该项目将开发一种微型拉曼光谱（RS）探头，可以集成到硬膜外针。这将是有史以来最小的RS探测器。在美国，每年有4500万例医疗手术依赖于将针头盲插或半盲插到组织中。并发症包括使人衰弱的头痛、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保健系统造成的损失超过200亿美元。每年，有1300万个硬膜外针被放置，12 - 27亿美元的直接医疗费用加上额外的持续医疗费用用于针错位。从离体组织研究中，我们发现RS可以区分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针，该探针可与硬膜外针（17号Tuohy针）结合。还将开发便携式临床原型设备。该器械将在MGH动物设施中通过活体动物研究进行确认。该系统的性能将与目前使用的阻力损失（LOR）硬膜外插入方法进行比较。

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.