Ergonomic fluorescence-guided surgery imaging platform for intraoperative assessment of blood and lymphatic vasculature

项目摘要/摘要 本提案旨在解决未得到满足的术中血液和淋巴管评估的临床需求。 血管系统可降低两种乳腺癌相关疾病的患病率：淋巴水肿和组织 坏死。目前的成像系统繁琐，需要关闭房间的灯，具有较差的性能 荧光敏感度，或提供难以解释的图像。OnLume将开发临床手推车- 基于Asimov成像平台与FDA批准的荧光染料吲哚青氨酸结合使用 绿色，这不仅可以在没有环境光的情况下实时捕获小船的图像 降级到图像对比度，但也易于外科医生使用和解释，从而产生一个将 经过优化，在乳腺癌手术工作流程中提供跨多个程序的临床价值。 在美国，每年有超过25万名女性接受乳腺癌手术。按照惯例， 外科医生依靠白光反射率作为评估血管通畅性的指南，这是极其困难的 想象一下。淋巴水肿是一种与淋巴管受损有关的不治之症，可发生在UP中。 至40%的乳腺癌幸存者；相关症状包括疼痛、沉重和活动受限，以及 相关费用每年从3000美元到16000美元不等。淋巴引流的淋巴切除术 乳房同时保留淋巴通道可能会降低淋巴水肿的风险。 一些接受乳房切除术的女性可能会选择用游离乳房瓣手术进行乳房再造， 整形外科医生在供体和受体组织部位之间重新连接血管以重建乳房 投手丘。外科医生必须评估血管的通畅性，以降低组织坏死和继发性疾病的风险 行动。在15%-25%的病例中，患者接受二次手术以纠正组织坏死，这会产生成本 每次手术的费用可能超过14,000美元。 我们的新型成像系统将在一项初步研究中进行评估，以衡量 血液和淋巴结构。这项第二阶段的建议有三个具体目标：(1)全面发展 并将新技术集成到临床瞬变照明、广域荧光引导中 基于手术车的成像平台，(2)显示腋窝反向淋巴管的增强对比 (3)评价游离瓣乳房重建术中血管通畅性。成功 建成后将产生一种可商业化的临床广域FGS成像系统，提供关键的 术中成像可以使乳房外科医生和整形外科医生改善健康和 乳腺癌幸存者的生活质量。

Project Summary/Abstract This proposal aims to address the unmet clinical need for intraoperative assessment of blood and lymphatic vasculature to reduce the prevalence of two breast cancer-related morbidities: lymphedema and tissue necrosis. Current imaging systems are cumbersome, requiring ambient room lights to be turned off, have poor fluorescence sensitivity, or provide images that are difficult to interpret. OnLume will develop the clinical cart- based Asimov Imaging Platform to work in combination with the FDA-approved fluorescent dye, indocyanine green, that not only enables real-time image capture of small vessels with ambient lights on without degradation to image contrast, but also is easy for surgeons to use and interpret resulting in a platform that will be optimized to provide clinical value across multiple procedures in the breast cancer surgery workflow. More than 250,000 women a year undergo surgery for breast cancer in the United States. Conventionally, surgeons rely on white light reflectance as a guide to assessing vessel patency, which is extremely difficult to visualize. Lymphedema, an incurable disease associated with damage to lymphatic vessels, may occur in up to 40% of breast cancer survivors; associated symptoms include pain, heaviness and limitations in motility and associated costs range from $3000 to $16,000 per annum. Resection of lymph nodes that drain from the breast while sparing the lymphatic channels may decrease the risk of lymphedema. Some women who undergo mastectomy may choose breast reconstruction with a free flap surgery, where plastic surgeons reattach blood vessels between donor and recipient tissue sites to reconstruct a breast mound. Surgeons must assess vessel patency to decrease the risk of tissue necrosis and secondary operations. In 15-25% of cases, patients undergo secondary surgery to correct tissue necrosis, incurring costs that can exceed $14,000 per procedure. Our novel imaging system will be evaluated in a pilot study to measure the efficacy of the visualization of the blood and lymphatic architecture. This Phase II proposal has three specific aims: (1) complete development and integration of novel technology into a clinical transient lighting-enabled, wide-field fluorescence-guided surgery cart-based imaging platform, (2) demonstrate enhanced contrast of lymphatics for axillary reverse mapping (ARM), and (3) evaluate blood vessel patency in free flap breast reconstruction. Successful completion will result in a commercially available clinical wide-field FGS imaging system, providing critical intraoperative imaging that could enable breast surgeons and plastic surgeons to improve the health and quality of life for breast cancer survivors.