Fluorescence Imaging Device with Edge Computing Capability for Intraoperative Vascular and Lymphatic Assessment

具有边缘计算能力的荧光成像设备，用于术中血管和淋巴评估

• 批准号: 10547603
• 负责人: Maziyar Askari Karchegani
• 金额: $ 59.99万
• 依托单位: UNIFY MEDICAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547603
• 关键词: 3-Dimensional; Adoption; Anastomosis - action; Angiography; Arteries; Augmented Reality; Blood Vessels; Bypass; Clinic; Clinical; Clinical Trials; Collaborations; Complement; Defect; Detection; Development; Devices; Diagnosis; Education; Failure; Feedback; Fluorescence; Fluorescence Angiography; Freedom; Funding; Future; Goals; Hand; Image-Guided Surgery; Imaging Device; Infection; Innovation Corps; Interview; Intuition; Iowa; Laboratories; Lead; Learning; Legal patent; Limb structure; Lymph Node Mapping; Lymphatic; Lymphography; Machine Learning; Medical; Medical Device; Methods; Mission; Modality; Modeling; Monitor; Multimodal Imaging; Ohio; Operative Surgical Procedures; Outcome; Performance; Perfusion; Peripheral arterial disease; Phase; Positioning Attribute; Privatization; Public Health; Rattus; Regulatory Pathway; Reporting; Research; Rodent Model; Running; Small Business Innovation Research Grant; Staging; Surgeon; Surgical Anastomosis; System; Testing; Time; Tissues; Traction; Training and Education; Transplantation; Transplantation Surgery; Ultrasonography; United States National Institutes of Health; Universities; Veins; Visualization; Voice; convolutional neural network; cost; disability; evidence base; fluorescence imaging; fluorescence-guided surgery; follow-up; hypoperfusion; imaging capabilities; imaging system; improved; improved outcome; in vivo; in vivo fluorescence imaging; innovation; lymphatic surgery; lymphatic vasculature; necrotic tissue; neural network; novel; programs; prototype; repaired; stereoscopic; surgery outcome; trauma surgery; ultrasound; user-friendly

Assessment of vasculatures and lymphatics is critical to surgery. Fluorescence angiography is an excellent method for identifying anastomotic failure. Intraoperative detection of anastomotic failures and hypoperfusion can reduce surgical re-exploration and follow-up surgery. For lymphatic surgery such as lymphovenous bypass, fluorescence lymphography is important for diagnosis, staging, and surgical planning. Unfortunately, commercially available fluorescence imaging systems are bulky, expensive, and not user-friendly. There is an unmet clinical need for an affordable and intuitive multiscale fluorescence imaging system suitable for diverse vascular and lymphatic assessment use cases. The long-term goal is to improve outcomes of microvascular, lymphatic, transplant, and trauma surgery by enhancing intraoperative imaging and tissue assessment. The overall objective in this application is to develop a wearable multiscale fluorescence imaging and 3D display device with edge computing capability. The project will be guided by the following specific aims: Aim 1. Develop a wearable multiscale fluorescence imaging and display device for vascular and lymphatic assessment. A compact prototype will be developed that offers real-time stereoscopic fluorescence imaging and 3D augmented reality display for vascular and lymphatic assessment. Multiscale fluorescence imaging with 2X-10X dynamic magnification will be implemented to accommodate diverse surgical applications, including lymphatic mapping, perfusion angiography, and anastomosis patency testing. Heterogeneous computing will be implemented to support machine learning tasks using deep convolutional neural networks. Voice control and autofocus will be implemented on the edge. Medical information including duplex ultrasound images will be overlaid in augmented reality. Aim 2. Characterize the device and demonstrate wearable multiscale fluorescence imaging in vivo. Comprehensively characterization of the system performance will be performed. Wearable multiscale fluorescence imaging will be demonstrated in a rat model. Lymphatic mapping (wide-field fluorescence imaging) and an anastomotic patency check (magnified fluorescence imaging) will be demonstrated in vivo. The proposed research is innovative, in applicant’s opinion, because it represents a substantive departure from the status quo by offering real-time multiscale fluorescence imaging capability and edge computing capability in a wearable 3D system. The proposed project is significant because it is expected to provide strong evidence-based proof of principle for further development and future clinical trials of the wearable multiscale fluorescence imaging device for vascular and lymphatic assessment. If the proposed device is successfully commercialized, surgeons will have access to an innovative product that can improve surgical outcomes of multiple surgical subspecialities.

血管和毛细血管的评估是手术的关键。荧光血管造影是一种很好的 用于识别吻合失败的方法。吻合失败和低灌注的术中检测 可减少手术再探查和后续手术。用于淋巴外科手术，如淋巴静脉 荧光淋巴造影术对于诊断、分期和手术计划是重要的。不幸的是， 商业上可获得的荧光成像系统体积大、价格昂贵，并且用户不友好。有一个 对适用于各种应用的经济实惠且直观的多尺度荧光成像系统的未满足的临床需求 血管和淋巴评估用例。长期目标是改善微血管的结果， 通过增强术中成像和组织评估，为淋巴、移植和创伤手术提供支持。的 本申请的总体目标是开发可穿戴的多尺度荧光成像和3D显示器 具有边缘计算能力的设备。该项目将遵循以下具体目标：目标1。 开发用于血管和淋巴管的可穿戴多尺度荧光成像和显示装置 考核一个紧凑的原型将开发提供实时立体荧光成像 以及用于血管和淋巴评估的3D增强现实显示。多尺度荧光成像 将实施2X-10 X动态放大，以适应不同的手术应用， 包括淋巴映射、灌注血管造影和吻合通畅性测试。异构 计算将被实现，以支持使用深度卷积神经网络的机器学习任务。 语音控制和自动对焦将在边缘实现。医学信息，包括双功超声 图像将被叠加在增强现实中。目标二。表征设备并演示可穿戴设备 体内多尺度荧光成像。系统性能的全面表征将 执行。可穿戴多尺度荧光成像将在大鼠模型中进行演示。淋巴绘图 （宽视野荧光成像）和吻合口通畅性检查（放大荧光成像） 在活体中证明。申请人认为，拟议的研究具有创新性，因为它代表了 通过提供实时多尺度荧光成像能力， 可穿戴3D系统中的边缘计算能力。这个项目很重要，因为它预计 为进一步开发和未来的临床试验提供强有力的循证原则证明， 用于血管和淋巴评估的可穿戴多尺度荧光成像设备。如果拟议的 如果该器械成功商业化，外科医生将获得一种创新产品， 多个外科亚专科的手术结局。