Label-free, Multimodality Diffuse Reflectance and Polarization-Based Proximity Probe for Iatrogenic Nerve Injury Prevention During Surgical Procedures

项目总结 我们建议开发一种新型的、无标签的基于多模式的传感探头，它可以提供实时 术中识别手术工具热损伤阈值范围内的神经。该工具将 促进在外科手术中预防直接/间接神经损伤(称为医源性神经损伤)， 因为它们是术后并发症的主要来源，例如慢性疼痛。在美国，慢性疼痛 管理是目前与阿片类药物相关的药物过量流行的一个主要共谋因素。每年，超过45 在美国进行了数百万次外科手术，估计其中10%到50%的手术会导致 慢性术后疼痛患者的预后。尽管不是至少450万慢性疼痛病例中的每一个 明确地归因于医源性神经损伤，但它仍然是一种重要的复发性年度 医疗保健问题。与此相关的是，对大规模神经损伤治疗研究的分析表明，25%、60%和 94%的坐骨神经、股神经和副神经损伤与医源性神经损伤有关。 此外，医源性神经损伤是手术后生活质量问题的显著特征，其范围包括 丧失感觉和运动功能，导致前述慢性疼痛和发病。据报道，2-3年 前列腺癌根治术后，约60%的男性仍因海绵体神经受损而阳萎。同样， 20%-60%的乳腺癌切除治疗幸存者遭受手术后慢性疼痛 降低他们的生活质量，肋间臂神经损伤是主要原因。即使在外科手术中 最小的神经损伤风险，如听神经瘤切除(1%)，脊柱侧弯手术(0.6%)，以及 甲状腺切除术(2-3.8%)神经损伤的后果可能是严重的：导致耳聋，截瘫， 甚至死亡。医源性神经损伤的相关财务影响是重大的。 由于失去就业和/或收入，以及医疗保健，个人面临着直接的经济成本 作为神经损伤的行业是诉讼的常见来源，82%的案件获得赔偿 例如，脊椎副神经损伤。医疗保健人员和提供者面临的风险 由于医源性神经损伤常见于喉神经，因此法医责任十分广泛。 在甲状腺手术中，三叉神经和下牙槽神经在面部和口腔手术中，肋间 胸外科手术中的神经，以及脊柱副神经、腓总神经、桡浅神经 神经、生殖股神经在各种其他手术中的分支。因此，自2015年起，法医 诉讼风险是全球术中神经监测市场价值22亿美元的主要驱动力，预计 到2025年，每年以4.79%的速度增长。我们建议的解决方案目标是填补当前可用的 通过推出一种有效的、商业上可行的产品，满足不断增长的需求。我们的概念验证 这项研究的目标是高后果的外科癌症治疗甲状腺切除手术。

PROJECT SUMMARY We propose to develop a novel contact, label-free multimodality-based sensing probe that provides real-time intraoperative identification of nerves within the thermal damage threshold range of a surgical tool. The tool will facilitate prevention of direct/indirect nerve damage (termed iatrogenic nerve injury) during surgical procedures, as they are a major source of postsurgical complications, e.g., chronic pain. In the United States, chronic pain management is a major complicit factor in the ongoing opioid-related drug overdose epidemic. Annually, over 45 million surgical procedures are performed in the United States and an estimated 10% to 50% of them result in chronic postoperative pain patient outcomes. Though not every one of the at least 4.5 million chronic pain cases are definitively ascribable to iatrogenic nerve injury, it nonetheless represents a significant recurrent annual healthcare problem. Relatedly, analysis of large-scale nerve lesion treatment studies ascribes 25%, 60% and 94% respectively of sciatic, femoral and accessory nerve lesions addressed to iatrogenic nerve injury. Additionally, iatrogenic nerve injury features prominently in post-surgical quality of life issues that range from loss of sensation and motor function, to the aforementioned chronic pain, and morbidity. Reportedly, 2-3 years post radical prostatectomy ~60% of men are still impotent as a result of damaged cavernous nerves. Likewise, 20% - 60% of mastectomy breast cancer treatment survivors suffer chronic post-surgical pain that significantly reduces their quality of life, and injury to the intercostobrachial nerve is the primary cause. Even in surgeries with minimal neural damage risk like acoustic neuroma removal (<1%), spinal scoliosis surgery (<0.6%), and thyroidectomy (<2-3.8%) the consequences of nerve damage can be severe: leading to deafness, paraplegia, and even death respectively. The associated financial implications of iatrogenic nerve damage are significant. There are direct financial costs to the individual due to loss of employment and/or income, and to the healthcare industry as nerve damage is a common source of litigation with compensation being awarded in 82% of cases of spinal accessory nerve injury, for an example. The exposure of healthcare personnel and providers to medicolegal liability is extensive as Iatrogenic nerve injuries are commonly reported on the laryngeal nerve during thyroid operations, trigeminal nerve and inferior alveolar nerve during facial and oral surgeries, intercostal nerves during thoracic surgeries, and on the spinal accessory nerves, common peroneal nerve, superficial radial nerve, and genitofemoral nerve branches during various other surgeries. Consequently, as of 2015, medicolegal litigation risk was a primary driver for a $2.2 billion global market for intraoperative nerve monitoring projected to grow annually at 4.79% until 2025. Our proposed solution targets filling both the deficiencies of currently available options and the growing demand by introducing an effective, commercially viable product. Our proof-of-concept study targets highly consequential surgical cancer treatment thyroidectomy procedures.