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

基于无标记、多模态漫反射和偏振的接近探头，用于预防手术过程中的医源性神经损伤

• 批准号: 10491034
• 负责人: Justin Baba
• 金额: $ 32.84万
• 依托单位: YAYA SCIENTIFIC, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491034
• 关键词: Acoustic Neuroma; Address; Algorithms; Automation; Award; Biophotonics; Blood; Breast Cancer Treatment; Cadaver; Cauterize; Cessation of life; Chronic; Clinical; Clinical Research; Collection; Consequentialism; Data; Data Analyses; Data Collection; Detection; Development; Devices; Diffuse; Dissection; Electrosurgery; Employment; Epidemic; Excision; Face; Financial compensation; Financial cost; Goals; Health Care Costs; Health Personnel; Healthcare; Healthcare Industry; Hemorrhage; Human; Hybrids; Iatrogenesis; Impotence; Income; Individual; Injury; Intellectual Property; Label; Laryngeal Nerves; Lasers; Legal Liability; Legal patent; Lesion; Link; Litigation; Mastectomy; Medical; Medical Care Costs; Medical Liabilities; Methods; Monitor; Morbidity - disease rate; Motor; Nerve; Numbness; Operative Surgical Procedures; Opioid; Oral Surgical Procedures; Overdose; Paraplegia; Patient-Focused Outcomes; Patients; Penetration; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Postoperative Pain; Postoperative Period; Prevention; Procedures; Process; Quality of life; Radical Prostatectomy; Rattus; Recovery; Recurrence; Reporting; Rights; Risk; Secure; Societies; Source; Spinal; Structure; Structure of radial nerve; Surgeon; Surgical incisions; Survivors; System; Systems Development; Technology; Testing; Thoracic Surgical Procedures; Thyroid Gland; Thyroidectomy; Time; Tissues; Trigeminal nerve structure; Ultrasonics; United States; Universities; Update; Ventral thoracic nerve structure; Work; absorption; algorithm development; base; cancer therapy; chronic pain; chronic pain management; contrast enhanced; cost; deafness; design; flexibility; health care delivery; improved; in vivo; inferior alveolar nerve; injury prevention; machine learning algorithm; men; multimodality; nerve damage; nerve injury; new technology; novel; operation; opioid use; overdose death; peroneal nerve; pre-clinical; prevent; prototype; relating to nervous system; scalpel; sciatic nerve; scoliosis; sensor technology; stem; tool

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.

项目摘要 我们建议开发一种新型的接触式，无标记的多模态传感探头，提供实时 在手术工具的热损伤阈值范围内的神经的术中识别。该工具将 有助于预防手术过程中的直接/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 在目前与类阿片有关的药物过量流行病中，管理是一个主要的同谋因素。每年，超过45 在美国进行了100万例外科手术，估计其中10%至50%导致 慢性术后疼痛患者结局。虽然不是每一个至少450万慢性疼痛病例 明确归因于医源性神经损伤，但它仍然代表了一个显着的复发性年度 医疗保健问题。相关地，对大规模神经损伤治疗研究的分析认为， 坐骨神经、股神经和副神经损伤的医源性神经损伤率分别为94%。 此外，医源性神经损伤在术后生活质量问题中表现突出， 感觉和运动功能的丧失、上述慢性疼痛和发病率。据报道，2-3年 根治性尿道切除术后，约60%的男性仍然由于海绵体神经受损而阳痿。同样地， 20% - 60%的乳房切除术乳腺癌治疗幸存者遭受慢性术后疼痛， 降低了他们的生活质量，肋间臂神经损伤是主要原因。即使在手术中， 最小的神经损伤风险，如听神经瘤切除（<1%），脊柱侧凸手术（<0.6%）， 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显着的。 由于失去就业和/或收入，个人以及医疗保健都有直接的财务成本。 神经损伤是诉讼的常见来源，82%的案件获得赔偿 脊髓副神经损伤医护人员和提供者暴露于 法医学责任是广泛的医源性神经损伤是常见的喉神经 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 神经和生殖股神经分支。因此，截至2015年，法医 诉讼风险是22亿美元的全球术中神经监测市场的主要驱动力， 到2025年，每年增长4.79%。我们提出的解决方案的目标是填补目前可用的 通过引入一种有效的、商业上可行的产品，来满足日益增长的需求。我们的概念验证 研究目标是高度后果性的外科癌症治疗甲状腺切除术。