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.

项目总结/摘要 在这个研发项目中，物理科学公司。(PSI)与达特茅斯希区柯克医疗公司合作 中心（DHMC），建议证明和商业化先进的术中荧光 成像器，可以有效地突出显示手术床中的神经存在，从而消除 神经损伤意外的神经损伤是许多手术发病的主要原因，特别是在软组织中。 组织整形外科、耳鼻喉科、颅面外科和泌尿生殖外科手术。独特的视觉效果 来自邻近结缔组织和脂肪组织的神经是具有挑战性的，因此神经损伤仍然是主要的 手术并发症基于神经标记剂的荧光引导手术（FGS）具有潜力 来提高神经识别能力FGS中的一个突出问题是强环境的负面影响 光，其干扰弱荧光信号。目前，这个问题通过关灯来缓解 在荧光成像过程中在手术室（OR）中。然而，这会导致不必要的 中断手术工作流程，从而挫伤外科医生的积极性， FGS技术的临床应用潜力。 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.所提出的技术使用新颖的时空调制（TSM）照明方案， 这显著地减小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鲁棒的成像器，其能够抑制环境光背景， 系数> 16，000。高的背景排斥率使高对比度神经的收集成为可能- 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 其临床使用的适用性和准备情况。第二阶段的工作重点是：1）提高技术水平， 通过结合同时双波长荧光和反射白光成像的性能; 2)通过广泛的体内动物研究证明该技术的益处; 3）评估 成像仪的临床适用性和就绪性;以及4）根据关键意见进行仪器演示 领导者和潜在客户的外联。该研发项目将为术中应用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 关闭室内灯以确保正常的手术流程。这将促进术中荧光成像 这些程序将无缝集成到当前的临床工作流程中，以获得最佳的患者结局。