Advanced Intraoperative Imager for Nerve Identification

用于神经识别的先进术中成像仪

• 批准号: 10481320
• 负责人: Youbo Zhao
• 金额: $ 89.03万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10481320
• 关键词: Adipose tissue; Adoption; Animal Experiments; Animals; Beds; Caliber; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Complication; Connective Tissue; Contrast Media; Development; Devices; Diffusion; Dyes; Environment; FDA approved; Fatty acid glycerol esters; Feedback; Fluorescence; Frequencies; Genitourinary system; Human; Iatrogenesis; Image; Image-Guided Surgery; Imaging Techniques; Imaging technology; Interruption; Label; Light; Lighting; Marketing; Medical center; Methods; Morbidity - disease rate; Nerve; Nerve Tissue; Noise; Operating Rooms; Operative Surgical Procedures; Orthopedics; Otolaryngology; Patient-Focused Outcomes; Performance; Phase; Predisposition; Readiness; Resolution; Risk; Scanning; Scheme; Secure; Signal Transduction; Specimen; Stains; Structure; Surgeon; Surgical complication; System; Technology; Time; Tissues; Validation; Variant; Visualization; base; clinical translation; commercialization; confocal imaging; contrast imaging; craniofacial; design; fluorescence imaging; fluorescence-guided surgery; fluorophore; human tissue; imager; imaging system; improved; in vivo; innovation; innovative technologies; instrument; nerve damage; nerve injury; novel; operation; optical imaging; outreach; physical science; pre-clinical; programs; prototype; recruit; research and development; research clinical testing; soft tissue; user-friendly

Project Summary/Abstract In this R&D program, Physical Sciences Inc. (PSI), in collaboration with Dartmouth Hitchcock Medical Center (DHMC), proposes to demonstrate and commercialize an advanced intraoperative fluorescence imager that can efficiently highlight nerve presence in the surgical bed and thus eliminate risk for nerve damage. Unintended nerve injury is a major cause of morbidity for many surgeries, especially in soft tissue orthopedic, otolaryngology, craniofacial, and genitourinary operations. Distinctive visualization of nerves from adjacent connective and fat tissues is challenging, and therefore nerve injury remains a major surgical complication. Fluorescence guided surgery (FGS) based on nerve-labelling agents has the potential to improve nerve identification. An outstanding problem in FGS is the negative impact of the strong ambient light, which interferes the weak fluorescence signal. Currently, this problem is mitigated by turning off the light in the operating room (OR) during the fluorescence imaging procedure. However, this causes unwanted interruption to the surgical workflow and thus dampens the enthusiasm of the surgeons and diminishes the potential for clinical adoption of FGS technologies. PSI and DHMC will develop a fluorescence imager that overcomes most of the issues of the current FGS systems. The proposed technology uses a novel tempo-spatially modulated (TSM) illumination scheme, which significantly reduces the negative impact of the ambient light background. During the Phase I effort, we successfully demonstrated a robust imager that is cable of suppressing the ambient light background by a factor of >16,000. The high rate of background rejection enabled the collection of high-contrast nerve- highlighting images under the regular high-brightness OR light. During the Phase II program, we propose to further optimize and mature this technology and demonstrate its suitability and readiness for clinical use. The Phase II effort will focus on: 1) improving the technical performance by incorporating simultaneous dual-wavelength fluoresce and reflection white-light imaging; 2) demonstrating the benefits of the technology through extensive in vivo animal studies; 3) evaluating the clinical suitability and readiness of the imager; and 4) performing instrument demonstrations to key opinion leaders and outreach to potential customers. This R&D project will lead to a reliable solution for intraoperative fluorescence imaging in the presence of standard OR lighting conditions, avoiding the interruption to the normal surgical workflow by turning off the room light. This will promote intraoperative fluorescence imaging procedures to be seamlessly integrated into current clinical workflows for optimal patient outcome.

项目概要/摘要 在该研发项目中，Physical Sciences Inc. (PSI) 与 Dartmouth Hitchcock Medical 合作 中心 (DHMC)，提议展示先进的术中荧光并将其商业化 成像仪可以有效地突出手术床上的神经存在，从而消除手术风险 神经损伤。意外的神经损伤是许多手术发病的主要原因，尤其是软组织手术 组织骨科、耳鼻喉科、颅面科和泌尿生殖科手术。独特的可视化 来自邻近结缔组织和脂肪组织的神经具有挑战性，因此神经损伤仍然是一个主要的问题 手术并发症。基于神经标记剂的荧光引导手术（FGS）具有潜力 以提高神经识别能力。 FGS的一个突出问题是强烈环境的负面影响 光，会干扰微弱的荧光信号。目前，这个问题可以通过关灯来缓解 在荧光成像过程中在手术室 (OR) 中进行。然而，这会导致不必要的 干扰了手术流程，从而挫伤了外科医生的积极性，降低了手术效果 FGS 技术临床应用的潜力。 PSI 和 DHMC 将开发一种荧光成像仪，克服当前 FGS 的大部分问题 系统。所提出的技术采用新颖的时空调制（TSM）照明方案， 这大大减少了环境光背景的负面影响。在第一阶段的努力中， 我们成功地展示了一种强大的成像仪，它可以通过以下方式抑制环境光背景： 系数 >16,000。高背景排斥率使得能够收集高对比度神经 在常规高亮度 OR 灯下突出显示图像。 在第二阶段计划中，我们建议进一步优化和成熟这项技术，并展示 其对临床使用的适用性和准备情况。第二阶段的工作重点是：1）改进技术 通过结合同时双波长荧光和反射白光成像来提高性能； 2）通过广泛的体内动物研究证明该技术的优势； 3）评估 成像仪的临床适用性和就绪性； 4）针对关键意见进行仪器演示 领导者和潜在客户的外展。该研发项目将为术中治疗提供可靠的解决方案 在标准 OR 照明条件下进行荧光成像，避免干扰 通过关闭房间灯来正常手术流程。这将促进术中荧光成像 程序无缝集成到当前的临床工作流程中，以获得最佳的患者治疗结果。