Real-time Multimodal Diffuse Reflectance and Polarization Imaging Based Nerve Identification in Surgical Field of View

基于实时多模态漫反射和偏振成像的手术视场神经识别

• 批准号: 10831112
• 负责人: Justin Baba
• 金额: $ 99.9万
• 依托单位: YAYA SCIENTIFIC, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-21 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10831112
• 关键词: Acceleration; Accidents; Acoustic Neuroma; Address; Algorithmic Software; Award; Biophotonics; Blinded; Breast Cancer Treatment; Cessation of life; Characteristics; Chronic; Clinical; Clinical Data; Clinical Research; Compensation; Data; Data Analyses; Detection; Development; Devices; Diffuse; Employment; Epidemic; Excision; Face; Feedback; Femur; Financial cost; Future; Generations; Goals; Health Care Costs; Health Personnel; Healthcare; Healthcare Industry; Hybrids; Iatrogenesis; Image; Image-Guided Surgery; Imaging Device; Impotence; Income; Individual; Injury; Intellectual Property; Label; Laryngeal Nerves; Legal patent; Lesion; Light; Litigation; Marketing; Mastectomy; Medical; Medical Care Costs; Medical Imaging; Medical Liabilities; Methods; Monitor; Morbidity - disease rate; Motor; Nerve; Nerve Tissue; Numbness; Operative Surgical Procedures; Opioid; Oral Surgical Procedures; Overdose; Paraplegia; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Postoperative Pain; Postoperative Period; Prevention; Process; Provider; Public Health; Quality of life; Radical Prostatectomy; Recurrence; Reporting; Research Design; Rights; Risk; Role; Safety; Secure; Small Business Technology Transfer Research; Societies; Source; Specificity; Spinal; Structure of radial nerve; Surgeon; Survivors; System; Techniques; Technology; Testing; Thoracic Surgical Procedures; Thyroid Gland; Thyroidectomy; Time; Tissues; Trigeminal nerve structure; United States; Universities; Update; Ventral thoracic nerve structure; Vertebral column; Visualization; absorption; chronic pain; chronic pain management; clinical implementation; contrast enhanced; cost; data acquisition; deafness; design; diffuse reflectance spectroscopy; efficacy testing; first-in-human; flexibility; health care delivery; human subject; imager; improved; in vivo; inferior alveolar nerve; injury prevention; men; multimodality; nerve damage; nerve injury; neural; novel; operation; opioid use; overdose death; pain outcome; peroneal nerve; preclinical study; prototype; scoliosis; software development; software systems; spared nerve; spectroscopic imaging

PROJECT SUMMARY We propose to develop a novel non-contact, label-free multimodality imager that provides real-time intraoperative identification of nerves within the surgical field-of-view to facilitate the prevention of unintended 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 putative contributing factor in the current 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 patient chronic postoperative pain outcomes. Though not all the at least 4.5 million are definitively ascribable to iatrogenic nerve injury, it nonetheless represents a significant recurring annual healthcare problem. Relatedly, analysis of large-scale nerve lesion treatment studies reveals that 25%, 60% and 94% respectively of sciatic, femoral and accessory nerve lesions addressed are caused by 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 2022, medicolegal litigation risk was a primary driver for a $1.5 billion global market for intraoperative nerve monitoring projected to grow at 5.1% annually through 2030. Our proposed solution targets filling both the deficiencies of currently available options and the growing demand by introducing an effective, commercially viable product.

项目摘要 我们建议开发一种新型的非接触式、无标记的多模态成像仪， 识别手术视野内的神经，以便于防止意外的神经损伤 （称为医源性神经损伤），因为它们是手术后神经损伤的主要来源。 并发症，例如，慢性疼痛在美国，慢性疼痛管理是一个主要的假定贡献 这是目前阿片类药物过量流行的一个因素。每年有超过4500万例外科手术 在美国进行，估计其中10%至50%导致患者慢性术后疼痛 结果。虽然不是所有的至少450万人都明确归因于医源性神经损伤， 然而，这仍然是一个重大的每年反复出现的卫生保健问题。与此相关的是， 神经损伤治疗研究显示，坐骨神经、股神经和副神经损伤分别为25%、60%和94 所述的神经损伤由医源性神经损伤引起。 此外，医源性神经损伤在术后生活质量问题中表现突出， 对上述慢性疼痛的感觉和运动功能的丧失以及发病率。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2022年，法医 诉讼风险是15亿美元全球术中神经监测市场的主要驱动力， 到2030年每年增长5.1%。我们提出的解决方案的目标是填补目前的不足， 通过引入有效的、商业上可行的产品，满足现有的选择和不断增长的需求。