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: 10158278
• 负责人: Justin Baba
• 金额: $ 33.34万
• 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 2022-03-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158278
• 关键词: Acoustic Neuroma; Address; Algorithms; Automation; Award; Biophotonics; Breast Cancer Treatment; Cessation of life; Characteristics; Chronic; Clinical; Clinical Research; Collection; Data; Data Analyses; Data Collection; Detection; Development; Device Designs; Devices; Diffuse; Employment; Epidemic; Excision; Face; Financial compensation; Financial cost; Goals; Health Care Costs; Health Personnel; Healthcare; Healthcare Industry; Hybrids; Iatrogenesis; Image; Image-Guided Surgery; Impotence; Income; Individual; Injury; Intellectual Property; Label; Laryngeal Nerves; Legal patent; Lesion; Litigation; Mastectomy; Mediation; Medical; Medical Care Costs; 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; Quality of life; Radical Prostatectomy; Rattus; Reporting; Rights; Risk; Secure; Societies; Source; Spinal; Structure; Structure of radial nerve; Surgeon; Survivors; System; Systems Development; Techniques; Technology; Testing; Thoracic Surgical Procedures; Thyroid Gland; Thyroidectomy; Time; Tissues; Trigeminal nerve structure; United States; Universities; Update; Ventral thoracic nerve structure; absorption; algorithm development; base; chronic pain; chronic pain management; contrast enhanced; cost; data visualization; deafness; design; diffuse reflectance spectroscopy; health care delivery; imager; in vivo; inferior alveolar nerve; injury prevention; machine learning algorithm; men; multimodality; nerve injury; novel; operation; opioid use; overdose death; pain outcome; peroneal nerve; pre-clinical; prototype; relating to nervous system; sciatic nerve; scoliosis; 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 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.

项目概要 我们建议开发一种新型非接触式、无标签多模态成像仪，提供实时术中成像 识别手术视野内的神经，以利于预防意外的神经损伤 （称为医源性神经损伤）在手术过程中，因为它们是术后神经损伤的主要来源 并发症，例如慢性疼痛。在美国，慢性疼痛管理被认为是一个主要的贡献因素 当前阿片类药物相关药物过量流行的因素。每年有超过 4500 万例外科手术 在美国进行，估计其中 10% 至 50% 会导致患者术后慢性疼痛 结果。虽然这至少 450 万例中并非全部都明确归因于医源性神经损伤，但 然而，这仍然是一个重大的、经常性的年度医疗保健问题。相关地，大规模分析 神经损伤治疗研究表明，坐骨神经损伤、股骨神经损伤和副神经损伤分别有 25%、60% 和 94% 所讨论的神经损伤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占有重要地位，这些问题包括： 感觉和运动功能丧失，导致上述慢性疼痛和发病。据了解，2-3年 根治性前列腺切除术后，约 60% 的男性由于海绵体神经受损而仍然阳痿。同样地， 20% - 60% 的乳房切除术乳腺癌治疗幸存者遭受明显的慢性术后疼痛 降低了他们的生活质量，而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，例如听神经瘤切除术（<1%）、脊柱侧凸手术（<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。医源性神经损伤的相关财务影响是巨大的。 由于失业和/或收入的损失以及医疗保健，个人会产生直接的财务成本 由于神经损伤是该行业常见的诉讼来源，82% 的案件都获得了赔偿 以脊髓副神经损伤为例。医护人员和提供者接触 由于医源性神经损伤常见于喉神经，因此法医学责任广泛 甲状腺手术期间、面部和口腔手术期间的三叉神经和下牙槽神经、肋间手术期间 胸外科手术期间的神经，以及脊髓副神经、腓总神经、浅桡神经 神经和生殖股神经分支在各种其他手术中。因此，截至 2015 年，法医学 诉讼风险是全球术中神经监测市场规模达 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。我们提出的解决方案的目标是填补当前可用的解决方案的缺陷 通过引入有效的、商业上可行的产品来满足选择和不断增长的需求。

项目成果

Label-free intraoperative nerve detection and visualization using ratiometric diffuse reflectance spectroscopy.

• DOI: 10.1038/s41598-023-34054-6
• 发表时间: 2023-05-10
• 期刊: Scientific reports
• 影响因子: 4.6

Measurement of rat and human tissue optical properties for improving the optical detection and visualization of peripheral nerves.

测量大鼠和人体组织的光学特性，以改善周围神经的光学检测和可视化。

• DOI: 10.1364/boe.488761
• 发表时间: 2023
• 期刊: Biomedical optics express
• 影响因子: 3.4
• 作者: Haugen,EzekielJ;Throckmorton,GrahamA;Walter,AlecB;Mahadevan-Jansen,Anita;Baba,JustinS
• 通讯作者: Baba,JustinS