Digital Surgical Magnification Device for Lymphatic Surgery

用于淋巴手术的数字手术放大装置

基本信息

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
项目类别：
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

项目摘要

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还多仅在美国，就有 56% 的乳腺癌幸存者在两岁时出现淋巴水肿。每年约有 200 万淋巴水肿患者依赖淋巴手术。由于淋巴管尺寸小，因此可以进行显微手术和超显微手术，从而实现有效的手术可视化。高倍放大对于淋巴手术至关重要。外科医生的长期目标是使本来就很复杂的淋巴手术变得更加具有挑战性。通过增强手术可视化来改善淋巴手术的结果。该项目的申请是开发一种用于淋巴手术的可穿戴高功率数字放大设备。将遵循以下具体目标：目标 1. 开发可穿戴式高功率数字放大镜将开发一个紧凑的原型，提供动态高功率 3D。用于计算机辅助淋巴手术的增强现实 (AR) 放大倍率 4 倍至 20 倍动态。将开发放大功能以实现淋巴管的最佳手术可视化。目标 2. 描述可穿戴设备的特性。数字放大装置并展示其在淋巴手术中的实用性系统性能。该设备将应用于生物训练模型中的淋巴手术。基于鸡大腿和啮齿动物体内模型拟议的项目在申请人的研究中具有创新性。意见，因为它通过提供动态 3D 数字化代表了对现状的实质性背离所提出的项目具有重要意义，因为它是可穿戴系统中具有 AR 功能的放大技术。预计将为进一步开发和未来的临床试验提供强有力的基于证据的原则证明如果所提议的设备成功的话，可穿戴式高功率数字放大设备将用于淋巴手术。商业化的淋巴外科医生和其他显微外科医生将可以获得一种创新产品可以改善手术效果并降低手术费用。