Advanced Intraoperative Imager for Nerve Identification
Advanced Intraoperative Imager for Nerve Identification
批准号:
10594515
负责人:
Youbo Zhao
金额:
$87.09万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
未结题
起止时间:
2019-09-16 至 2025-03-31
关键词:
Adipose tissueAdoptionAnimal ExperimentsAnimalsBedsClinicalClinical ResearchClinical TrialsCollaborationsCollectionCommunitiesComplicationConnective TissueContrast MediaDevelopmentDevicesDiameterDiffusionDyesEnvironmentFDA approvedFatty acid glycerol estersFeedbackFluorescenceFrequenciesGenitourinary systemHumanIatrogenesisImageImage-Guided SurgeryImaging TechniquesImaging technologyInterruptionLabelLightLightingMarketingMedical centerMethodsMorbidity - disease rateNerveNerve TissueNoiseOperating RoomsOperative Surgical ProceduresOrthopedicsOtolaryngologyPatient-Focused OutcomesPerformancePhasePredispositionReadinessResolutionRiskScanningSchemeSecureSignal TransductionSpecimenStainsStructureSurgeonSurgical complicationSystemTechnologyTimeTissuesValidationVariantVisualizationclinical translationcommercializationcontrast imagingcraniofacialdesignfluorescence imagingfluorescence-guided surgeryfluorophorehuman tissueimagerimaging systemimprovedin vivoinnovationinnovative technologiesinstrumentmeternerve damagenerve injurynoveloperationoptical imagingoutreachphysical sciencepre-clinicalprogramsprototyperecruitresearch and developmentresearch clinical testingsoft tissueuser-friendly
中文摘要
项目总结/文摘
英文摘要
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.
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科研奖励(0)
会议论文
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