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.

抽象的 光学成像系统构成当今医学中最大的技术市场领域，主导工具 许多手术和胃肠病学专业的发展。然而，当高级光学成像设备是 与放射学设备相比，发生的校准，验证和标准化缺乏明显的情况。 缺乏多中心校准的方法，供应商之间的标准化以及有关监管的指导 各个供应商的性能目标，所有这些都导致效率高且缺乏可重复性，并且缺乏 能够与放射学常规进行相同用途的成像系统进行切换。更复杂的之一 但是，组织中光学成像的关键因素是考虑组织光学特性，光谱范围的关键因素 组织层/深度以非线性和非直觉方式影响图像质量。在此应用程序中，我们 开发一个隐式可扩展的企业，3D打印的手术设备测试目标，耦合到咨询网络 用于性能评估，验证，系统比较，多中心试验协调和平台间 比较更换性和FDA清除率。为了支持这项工作，我们开发了基于云的软件 用于测试结果的数据存储，用户的培训协议和网络一组来自学者的专家用户， 三个手术专业和行业，以迭代改善价值主张。目标1的重点 应用程序将通过3D打印完全自动化测试目标，以允许最简单 每个订单的生产链。 AIM 2通过硬化我们的绩效评估目标来遵循 根据目标的衡量，与我们的专家一起迭代为单个系统提出建议 每项通用手术，头颈外科手术以及神经外科手术的顾问。该提案是在多年的 专业任务组对问题的研究以及对关键目的的识别，包括（i）自动化 生产，ii）至少在至少6个中心分发至少2种设计，以及（iii）培训和专业 该领域的指导。这项工作的结果直接用于荧光引导手术，因为它是 新兴范式。通过独特的系统功能与众不同的新公司的增长 建立一个新的510（k）清除设备可能具有相同迹象的市场，但在 光谱范围，增强率，实时显示功能，因此对标准化的需求更加 今天至关重要。客观的绩效评估将有助于均质绩效和使用并提供 学者，手术和工业指导。不过，除了这个领域之外，这些目标的扩展为更多 医学中使用的传统光学成像工具也会自然会发生，我们的自定义咨询和 生产，当我们建立这个平台，行业和学术网络时。