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，无标签的基于多模式的传感探针，可提供实时 手术工具的热损伤阈值范围内神经的术中识别。该工具将 促进手术过程中预防直接/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 管理是正在进行的阿片类药物相关药物过量流行的主要同谋。每年超过45岁 在美国进行了数百万个手术程序，其中估计有10％至5​​0％导致 慢性术后患者结局。虽然并非至少有450万个慢性疼痛病例中的每一个 尽管如此，它明确地归因于医源性神经损伤，但它仍然代表了一年一度的重复年度 医疗保健问题。相关的是，大规模神经病变治疗研究的分析归因于25％，60％和 坐骨神经损伤的坐骨神经，股神经病变分别为94％。 此外，医源性神经损伤在术后生活质量问题中突出特征，范围从 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 根治性前列腺切除术大约60％的男性由于神经神经受损而无能为力。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 降低其生活质量，对术间神经的伤害是主要原因。即使在手术中 最小的神经损伤风险，例如声学神经瘤（<1％），脊柱脊柱侧弯手术（<0.6％）和 甲状腺切除术（<2-3.8％）神经损伤的后果可能很严重：导致耳聋，截瘫， 甚至分别死亡。医源性神经损害的相关财务影响是显着的。 由于失业和/或收入，个人有直接的财务成本，以及医疗保健 行业作为神经损害是诉讼的常见来源，在82％的案件中获得赔偿金 例如，脊柱辅助神经损伤。医疗保健人员和提供者接触 医源性神经损伤通常在喉神经上报道，医源性神经损伤是广泛的 在甲状腺作战过程中，面部和口腔手术期间三叉神经和下肺泡神经 胸外科手术期间的神经和脊柱辅助神经，常见的peroneal神经，表面radial 在其他各种手术过程中，神经和生殖股神经分支。因此，截至2015年，Medicolegal 诉讼风险是全球22亿美元全球市场的主要驱动力，用于术中神经监测预计 每年以4.79％的增长到2025年。我们提出的解决方案目标填补了当前可用的两种缺陷 通过引入有效的商业上可行的产品，期权和需求不断增长。我们的概念证明 研究针对高度结果手术癌症治疗甲状腺切除术。