STTR Phase I: Optical Sensor for Guiding Medical Needles

STTR 第一阶段：用于引导医用针的光学传感器

• 批准号: 1549613
• 负责人: Jeon Woong Kang
• 金额: $ 22.5万
• 依托单位: Biosight, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1549613&HistoricalAwards=false
• 关键词: STTR; Phase; Optical; Sensor; Guiding

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.

如果成功，该小型企业技术转移研究 (STTR) 第一阶段项目将具有更广泛的影响/商业潜力，从而能够开发出有史以来最小的具有拉曼光谱功能的光纤探头。更小的拉曼探头的优化将改善广泛的临床应用，例如心脏血管造影过程中的冠状动脉斑块诊断。此外，所提出的技术代表了一种基于非侵入性光子传感技术的新型“智能”手术工具。通过将智能算法集成到各种手术工具中，该团队希望提高患者的安全性，同时降低手术并发症造成的医疗成本。最后，生物光子技术的存在可以改善患者护理和临床结果。然而，其中许多药物价格昂贵，并不能降低总体医疗费用。由于医疗费用目前是国家预算的优先事项，因此开发能够在这两个方面提供改进的生物光子技术是当务之急。预计低成本、易于使用、基于光谱的置针技术不仅可以提高各种外科手术的安全性，而且可以通过降低因针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，该探头可以集成到硬膜外针中。这将是迄今为止开发的最小的 RS 探头。美国每年进行四千五百万例医疗程序，这些程序依赖于盲或半盲将针插入组织。并发症包括使人衰弱的头痛、脊髓损伤、感染、出血、器官损伤和手术无效。这些并发症给美国医疗保健系统造成的损失每年超过 200 亿美元。每年放置 1,300 万根硬膜外针，因针错位而产生 1.2-27 亿美元的直接医疗费用以及额外的持续医疗费用。通过离体组织研究，我们表明 RS 可以区分从皮肤到脊髓的每个组织层。在 STTR 第一阶段期间，该团队将开发一种微型拉曼探针，可以将其纳入硬膜外针（17 号 Tuohy 针）中。还将开发便携式临床原型设备。该设备将通过麻省总医院动物设施的活体动物研究进行验证。该系统的性能将与目前使用的阻力损失 (LOR) 硬膜外插入方法进行比较。