System and method for automatic perfusion measurement
Inventors
Lund, Morten Toft • Madsen, Mads Holst Aagaard
Assignees
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Publication Number
US-11911139-B2
Publication Date
2024-02-27
Expiration Date
Abstract
The present disclosure relates to a system and a method for automatically measuring and assessing hemodynamics in tissue of an anatomical structure of a subject. In particular the present disclosure relates to continuously measuring and assessing hemodynamics in medical procedures using fluorescence imaging and wherein the administration of the fluorescent agent is controlled and automated. One aspect relates to a method of automatic perfusion assessment of an anatomical structure of a subject, the method comprising administration into a vein of a bolus corresponding to less than 0.005 mg ICG/kg body weight of a first fluorescence imaging agent.
Core Innovation
The invention is an automatic blood perfusion assessment method for tissue of an anatomical structure of a subject. It administers a first fluorescence imaging agent as a first bolus into a vein and then administers a series of subsequent boluses with a predefined time between them. The bolus amount is dissolved in a liquid and corresponds to less than 0.005 mg ICG/kg body weight.
A central element of the invention is the low-dose bolus series used to acquire a fluorescence time series that reflects blood perfusion dynamics. The method acquires and analyses a time series of fluorescence images of the tissue following administering the first bolus, producing an analysis based on fluorescence intensity in the images. The method determines at least one blood perfusion parameter of the anatomical structure based on the analysis.
The invention is further directed to determining perfusion parameters from fluorescence intensity behaviour after the bolus administration and optionally using this to identify perfusion disruptions. Dependent aspects refine the anatomical structures to the gastrointestinal tract and refine fluorescence imaging agent options, including indocyanine green (ICG) and other named fluorescent compounds. The method can additionally localize a perfusion complication within the anatomical structure based on the perfusion assessment.
Claims Coverage
The document provides one independent claim. It covers an automated perfusion-assessment workflow based on a low-dose fluorescence agent bolus series, fluorescence time-series acquisition and intensity-based analysis, and determination of blood perfusion parameters, with dependent claims refining bolus dosing and sequencing, anatomical structure scope, fluorescence agent selection, and optional localization of a perfusion complication.
Low-dose fluorescence bolus series into a vein
Administering a first fluorescence imaging agent having an emission maximum into a vein of the subject as a first bolus and a series of subsequent boluses with a predefined time between the subsequent boluses, wherein the first bolus and each subsequent bolus comprise an amount of the first fluorescence imaging agent corresponding to less than 0.005 mg ICG/kg body weight and wherein the amount is dissolved in a liquid.
Time-series fluorescence imaging intensity analysis
Acquiring and analysing a time series of fluorescence images of the tissue following administering the first bolus, producing an analysis based on a fluorescence intensity in said images.
Determining blood perfusion parameters from analysis
Determining at least one blood perfusion parameter of said anatomical structure based on said analysis.
Refined subsequent bolus sequencing and timing intervals
Administering at least 3 or at least 5 subsequent boluses with predefined time intervals between boluses that fall within specified ranges.
Initial dose and incremental changes across boluses
Providing an initial amount of a first fluorescence imaging agent at least 0.001 mg ICG/kg body weight and less than 0.005 mg ICG/kg, with each subsequent bolus containing an incremental increase or incremental decrease of the first fluorescence imaging agent by between at least 0.001 mg ICG/kg body weight relative to the previous bolus.
Gastrointestinal tract tissue assessment
Performing the method using an anatomical structure comprising the gastrointestinal tract, including specified regions from the buccal cavity through the anal canal.
Fluorescence imaging agent selection including ICG and additional compounds
Using a fluorescence imaging agent that includes indocyanine green (ICG) and one or more specified fluorescent compounds, optionally combined with a targeting ligand.
Localization of a perfusion complication
Including localizing a perfusion complication within an anatomical structure as part of the perfusion assessment.
Overall claim coverage centres on an automated approach that uses a low-dose fluorescence imaging agent bolus series into a vein, time-series fluorescence imaging intensity analysis, and determination of blood perfusion parameters, with refinements covering bolus count and timing, dose constraints and incremental dosing changes, gastrointestinal tract scope, specified fluorescence agents including ICG and additional named compounds, and optional perfusion-complication localization.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Automated blood perfusion assessment of tissue during medical procedures, with gastrointestinal tract and anastomosis guidance explicitly described in the provided content.
Assessment involving skin flaps, wounds, and artery perfusion area and vein drainage area, as explicitly described in the provided content.
Other surgical contexts including bowel surgery, resection, and intestinal anastomosis, as explicitly described in the provided content.
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