Fluorescence Guided Surgery Standardization Tools

荧光引导手术标准化工具

• 批准号: 10074698
• 负责人: Ethan Phillip Marshall LaRochelle
• 金额: $ 26.64万
• 依托单位: QUEL IMAGING LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10074698
• 关键词: 3D Print; Accounting; Adoption; Advocacy; Advocate; Affect; Automation; Biomedical Research; Calibration; Clinical Trials; Computer software; Consult; Coupled; Custom; Data; Data Storage and Retrieval; Devices; Educational workshop; Evaluation; Feedback; Fluorescence; Future; Gastroenterology; Geometry; Goals; Group Identifications; Growth; Hand; Head and Neck Surgery; Image; Image-Guided Surgery; Imaging Device; Individual; Industrialization; Industry; Leadership; Manufacturer Name; Measures; Medical; Medicine; Methodology; Methods; Multicenter Trials; Operative Surgical Procedures; Optics; Outcome; Paper; Performance; Phase; Production; Property; Protocols documentation; Publishing; Radiologic Technology; Radiology Specialty; Recommendation; Reporting; Reproducibility; Risk; Running; Sales; Signal Transduction; Small Business Innovation Research Grant; Standardization; Surgical Specialties; System; Technology; Test Result; Testing; Time; Tissues; Training; Translations; Validation; Variant; Vendor; Work; base; career networking; cloud based; cost; cost effective; design; fluorescence-guided surgery; imaging system; improved; medical specialties; member; neurosurgery; optical imaging; prototype; symposium; tissue phantom; tool; tool development; web interface

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.

摘要 光学成像系统是当今医学领域最大的技术市场， 在许多外科和胃肠病学专业的发展。然而，当先进的光学成像设备 与放射性设备相比，完全缺乏校准、验证和标准化。 缺乏多中心校准方法、供应商之间的标准化以及 跨供应商的性能目标，所有这些都导致高效率和缺乏可重复性，以及缺乏 能够切换成像系统用于相同的用途，就像在放射学中常规进行的那样。一个比较复杂的 但组织中光学成像的关键因素是组织的光学特性、光谱范围 并且组织层/深度以非线性和非直观的方式影响图像质量。在本申请中，我们 开发一个隐含可扩展的企业，3D打印手术设备测试目标，与咨询网络相结合 用于性能评估、验证、系统比较、多中心试验协调和平台间 互换性和FDA许可的比较。为了支持这项工作，我们开发了基于云的软件， 测试结果的数据存储，用户的培训协议和网络一组来自学术界的专家用户， 三个外科专业和行业，以迭代方式改善价值主张。目标1的重点是 应用程序将通过3D打印实现测试目标生产的完全自动化，以允许最简单的 供应链的生产与每一个订单。目标2紧接着强化我们的绩效评估目标 根据目标衡量，与我们的专家一起迭代地为各个系统制定建议 普通外科、头颈外科和神经外科的顾问。该提案是在多年来 由一个专业工作组研究这一问题，并确定主要目标，包括：（一） 生产，ii）在至少6个中心分发至少2种设计，以及（iii）培训和专业人员 指导外地。这项工作的结果直接针对荧光引导手术，因为它是一种 新兴范式通过独特的系统功能使自己与众不同的新公司的增长 使得新的510（k）许可器械可能具有相同的适应症，但在以下方面存在差异 光谱范围、放大率、实时显示能力等，对标准化的需求甚至更多。 今天必不可少。客观的绩效评估将有助于使绩效均匀化， 为学术界、外科界和工业界提供指导。然而，在这个领域之外，这些目标的扩展到更多 医学中使用的传统光学成像工具也将自然发生，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。