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Advanced Intraoperative Imager for Nerve Identification

用于神经识别的先进术中成像仪

基本信息

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
项目类别：
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

项目摘要

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/文摘