Advanced Intraoperative Imager for Nerve Identification

用于神经识别的先进术中成像仪

• 批准号: 10594515
• 负责人: Youbo Zhao
• 金额: $ 87.09万
• 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 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10594515
• 关键词: Adipose tissue; Adoption; Animal Experiments; Animals; Beds; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Communities; Complication; Connective Tissue; Contrast Media; Development; Devices; Diameter; 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; clinical translation; commercialization; contrast imaging; craniofacial; design; fluorescence imaging; fluorescence-guided surgery; fluorophore; human tissue; imager; imaging system; improved; in vivo; innovation; innovative technologies; instrument; meter; 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.

项目摘要/摘要 在此研发计划中，物理科学公司（PSI）与达特茅斯·希区柯克医学合作 中心（DHMC）提议演示和商业化术中晚期荧光 图像仪可以有效地突出手术床中神经的存在，从而消除了 神经损伤。意外神经损伤是许多手术发病的主要原因，尤其是在软中 组织骨科，耳鼻喉科，颅面和泌尿生殖器作战。独特的可视化 来自相邻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主要的 手术并发症。基于神经标志剂的荧光引导手术（FGS）具有潜力 改善神经识别。 FGS中的一个杰出问题是强大环境的负面影响 光，会干扰弱荧光信号。目前，通过关闭光线来减轻此问题 在荧光成像过程中的手术室（或）中。但是，这会导致不必要的 中断外科手术工作流程，从而抑制了外科医生的热情并减少 FGS技术的临床采用潜力。 PSI和DHMC将开发一个荧光成像仪，该成像仪克服当前FG的大多数问题 系统。提出的技术使用新型的节气空间调制（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个强大的成像仪，该成像仪是通过抑制环境光背景的电缆 一个> 16,000的因素。高背景拒绝率使高对比度神经的收集 在常规的高亮度或光线下突出显示图像。 在第二阶段计划中，我们建议进一步优化和成熟这项技术，并证明 它适合临床用途。第二阶段的努力将重点放在：1）提高技术 通过合并同时的双波长荧光和反射白光成像来表现； 2）通过广泛的体内动物研究来证明技术的好处； 3）评估 成像仪的临床适合和准备性； 4）对关键意见进行仪器演示 领导者并向潜在客户推广。该研发项目将为术中提供可靠的解决方案 在标准或照明条件下的荧光成像，避免中断 通过关闭房间的光线，正常的手术工作流程。这将促进术中荧光成像 将无缝集成到当前的临床工作流程中，以获得最佳患者结果。