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

基本信息

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
项目类别：
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

项目摘要

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，无标签的多模式成像器，可提供实时术中识别手术视野内神经，以促进预防意外神经损伤（称为医源性神经损伤）在外科手术过程中，因为它们是手术后的主要来源并发症，例如慢性疼痛。在美国，慢性疼痛管理是一个主要的推定贡献当前与阿片类药物相关的药物过量流行的因素。每年超过4500万手术程序在美国进行，估计有10％至50％导致患者慢性术后疼痛结果。尽管并非所有至少450万的人都完全可以归因于医源性神经损伤，但它尽管如此，还是一个重大的年度医疗保健问题。相关，大规模分析神经病变治疗研究表明，坐骨神经，股骨和附件分别为25％，60％和94％涉及的神经病变是由医源性神经损伤引起的。此外，医源性神经损伤在术后生活质量问题中突出特征，范围从上述慢性疼痛和发病率的感觉和运动功能的丧失。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2022年，Medicolegal 诉讼风险是15亿美元全球市场的主要驱动力，用于预计的术中神经监测到2030年每年增加5.1％。我们提出的解决方案目标填补了当前的两种缺陷可用的选项和不断增长的需求，通过引入有效的，商业上可行的产品。