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.
