Digital Surgical Magnification Device for Lymphatic Surgery

用于淋巴手术的数字手术放大装置

• 批准号: 10256159
• 负责人: Maziyar Askari Karchegani
• 金额: $ 39.98万
• 依托单位: UNIFY MEDICAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256159
• 关键词: 3-Dimensional; Address; Adoption; Agreement; Animal Model; Augmented Reality; Biological; Biological Models; Breast Cancer survivor; Chickens; Clinical; Clinical Trials; Computer Assisted; Curative Surgery; Development; Devices; Edema; Education; Environment; Feedback; Felis catus; Freedom; Funding; Future; Goals; HIV; Infection; Innovation Corps; Interview; Intuition; Iowa; Joints; Laws; Lead; Learning; Legal patent; Lymphatic; Lymphatic Diseases; Lymphatic Research; Lymphatic System; Lymphedema; Marketing; Medical; Medical Device; Microscope; Microsurgery; Mission; Modeling; Motion; Ohio; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; Positioning Attribute; Privatization; Public Health; Regulatory Affairs; Regulatory Pathway; Reporting; Research; Rodent Model; Small Business Innovation Research Grant; Spinal; Surgeon; System; Techniques; Telemedicine; Thigh structure; Traction; Training; United States National Institutes of Health; Universities; Visualization; Voice; augmented reality headset; base; cost; digital; disability; evidence base; experience; improved; improved outcome; in vivo; innovation; lymphangiosarcoma; lymphatic surgery; lymphatic vessel; meetings; novel; product development; programs; prototype; surgery outcome; tool; user-friendly; wearable sensor technology

There are more patients suffering from lymphatic diseases than patients suffering from human immunodeficiency virus (HIV). In the US alone, 56% of breast cancer survivors develop lymphedema at two years, leading to approximately two million lymphedema patients annually. Lymphatic surgery relies on microsurgery and supermicrosurgery due to the small size of lymph vessels. Effective surgical visualization and high-power magnification are critical to lymphatic surgery. The lack of clinical tools available to lymphatic surgeons makes the already complicated lymphatic surgery even more challenging. The long-term goal is to improve outcomes of lymphatic surgery by enhancing surgical visualization. The overall objective of this application is to develop a wearable high-power digital magnification device for lymphatic surgery. The project will be guided by the following specific aims: Aim 1. Develop a wearable high-power digital magnification device for lymphatic surgery. A compact prototype will be developed that offers dynamic high-power 3D magnification with augmented reality (AR) for computer-aided lymphatic surgery. 4X-20X dynamic magnification will be developed for optimal surgical visualization of lymphatics. Autofocus and voice control will be implemented to cater to the demanding environment of lymphatic surgery. Aim 2. Characterize the wearable digital magnification device and demonstrate its utility in lymphatic surgery. System performance will be comprehensively characterized. The device will be applied to lymphatic surgery in a biological training model based on a chicken thigh and in vivo in a rodent model. The proposed project is innovative, in the applicant’s opinion, because it represents a substantive departure from the status quo by offering dynamic 3D digital magnification with AR capability in a wearable 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 wearable high-power digital magnification devices in lymphatic surgery. If the proposed device is successfully commercialized, lymphatic surgeons and other microsurgeons will have access to an innovative product that can improve surgical outcomes and reduce surgical costs.

患有淋巴疾病的患者比患有人类疾病的患者更多。 免疫缺陷病毒（HIV）。仅在美国，56%的乳腺癌幸存者在2岁时就会出现水肿。 年，导致每年约200万水肿患者。淋巴手术依赖于 由于淋巴管的尺寸小，因此可以进行显微手术和超显微手术。有效的手术可视化 和高倍放大对淋巴外科手术至关重要。缺乏临床工具可用于淋巴 外科医生使本已复杂的淋巴手术更具挑战性。长期目标是 通过增强手术可视化来改善淋巴手术的结果。本报告的总体目标 本申请旨在开发一种用于淋巴外科手术的可穿戴式高功率数字放大装置。项目 将遵循以下具体目标：目标1。开发一种可穿戴的大功率数字放大镜 淋巴外科手术器械。一个紧凑的原型将被开发，提供动态高功率3D 增强现实（AR）放大用于计算机辅助淋巴手术。4X-20 X动态 将开发放大率以获得最佳的外科手术可视化。自动对焦和语音控制将 实施，以满足淋巴外科手术的苛刻环境。目标2.描述可穿戴设备的特征 数字放大装置，并证明其在淋巴外科手术中的实用性。系统性能将 综合特征。该设备将在生物训练模型中应用于淋巴外科手术 基于鸡大腿和在啮齿动物模型中的体内。该项目是创新的，在申请人的 意见，因为它代表了一个实质性的偏离现状，提供动态3D数字 在可穿戴系统中具有AR能力的放大。该项目之所以重要，是因为 预计将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。 可穿戴式高功率数字放大设备在淋巴外科手术中的应用。如果所提议的装置成功地 商业化后，淋巴外科医生和其他显微外科医生将能够获得一种创新产品， 可以改善手术效果并降低手术成本。