Fluorescence Guided Surgery Standardization Tools

摘要 光学成像系统构成了当今医学最大的技术市场部门，主导着工具 在许多外科和胃肠病专业的发展。然而，当先进的光学成像设备 与放射设备相比，存在严重缺乏校准、验证和标准化的情况。 缺乏多中心校准的方法、供应商之间的标准化以及监管指导 所有供应商的性能目标都会导致效率很低，缺乏可重复性，并且缺乏 能够为相同的用途切换成像系统，这是放射学中的常规做法。其中一个比较复杂的 但在组织中进行光学成像的关键因素是如何解释组织的光学属性、光谱范围 组织层/深度以非线性和非直观的方式影响图像质量。在此应用程序中，我们 开发可隐式扩展的企业、3D打印手术设备测试目标，并与咨询网络相结合 用于性能评估、验证、系统比较、多中心试验协调和跨平台 互换性和FDA清除性的比较。为了支持这一努力，我们开发了基于云的软件 测试结果的数据存储，用户的培训协议和来自学术界的一组专家用户的网络， 三个外科专业和行业，不断提升价值主张。目标1的重点是 应用程序将通过3D打印完全自动化生产测试目标，以允许最简单的 供应链的生产与每一个订单。目标2随后强化了我们的绩效评估目标 根据目标来衡量，与我们的专家一起迭代地为各个系统开发建议 普外科、头颈外科和神经外科的顾问。这项提议是在多年的 由一个专业工作组研究这一问题并确定主要目标，包括：(1)自动化 制作，ii)在至少6个中心分发至少2个设计，以及(Iii)培训和专业人员 实地指导。这项工作的结果是直接针对荧光引导手术，因为它是一个 新兴范式。通过独特的系统功能使自己脱颖而出的新公司的增长 适用于这样一个市场，即新的510(K)许可设备可能具有相同的适应症，但在 光谱范围、放大倍数、实时显示能力等对标准化的需求更大 今天是必不可少的。客观的绩效评估将有助于使性能和使用同质化，并提供 对学者、外科医生和工业界的指导。然而，在这个领域之外，这些目标的扩展到更多 用于医学的传统光学成像工具也将自然而然地出现，我们的定制咨询和 生产，因为我们建立了这个平台和行业和学术网络。

Abstract Optical imaging systems form the largest technological market sector in medicine today, dominating tool development in many surgical and gastroenterology specialties. Yet when advanced optical imaging devices are compared to radiological devices, there is a stark lack of calibration, validation and standardization which occurs. The lack of methods for multicenter calibration, standardization between vendors, and regulatory guidance on performance targets across vendors, all leads to a high inefficiency and lack of reproducibility, and a lack of the ability to switch imaging systems for the same use, as is done routinely in radiology. One of the more complicated but critical factors with optical imaging in tissue is accounting for how tissue optical properties, spectral range and tissue layers/depths affect the image quality in non-linear and non-intuitive ways. In this application, we develop an implicitly scalable venture, 3D printed surgical device test targets, coupled to a consulting network for performance evaluation, validation, system comparison, multi-center trial coordination, and inter-platform comparisons for inter-changeability and FDA clearance. To support the effort, we develop cloud based software data storage for test results, training protocols for users and network a group of expert users from academics, three surgical specialties and industry, to iteratively improve the value proposition. The focus of aim 1 in this application will be on complete automation of production of the test targets via 3D printing, to allow the simplest supply chain of production with each order. Aim 2 follows by hardening up our performance assessment goals as measured by the targets, iteratively developing recommendations for the individual systems with our expert consultants in each of general surgery, head and neck surgery and neurosurgery. The proposal follows years of study of the issue by a professional task group and identification of the key aims, including (i) automation of production, ii) distribution of at least 2 designs across at least 6 centers, and (iii) training and professional guidance for the field. The outcome of this work is directly targeted for fluorescence guided surgery as it is an emerging paradigm. The growth in new companies who differentiate themselves by unique system capabilities makes for a market where new 510(k) cleared devices may have the same indication, yet have differences in spectral ranges, magnifications, real-time display capabilities, and so the need for standardization is even more essential today. Objective performance evaluation will help homogenize performance and use and provide guidance to academics, surgery and industry. Beyond this field though, the extension of these targets to more traditional optical imaging tools used in medicine will also naturally occur as will our custom consulting and production, as we establish this platform and industry and academic networks.