Interventional Hemodynamic Assistance Device for FFR Measurement
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Solution Overview
Problem
Invasive catheter-based pressure measurements for functional stenosis assessment lack reliability, completeness, and consistency due to limited practitioner assistance, varying results between patients and practitioners, and the need for improved characterization of coronary artery flow and resistance.
Innovation Solution
An assistance device combining fractional flow reserve pressure measurements with angiography-based coronary vessel geometry assessment, utilizing an advanced computational fluid dynamics model to pre-calculate optimal measurement positions and provide advice to interventional cardiologists, incorporating CT overlay for vessel tree segmentation and simulation-based stability analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive catheter-based pressure measurements are performed without advanced assistance systems, then the procedure is simple to perform, but the reliability and completeness of measurement results vary between patients and practitioners
Solution Approach 1:
The system performs pre-interventional planning by segmenting the vessel tree from CT angiography data and pre-calculating optimal measurement positions before the actual intervention. This preliminary action ensures that the most reliable measurement positions are identified in advance, reducing variability between practitioners during the actual procedure.
Solution Approach 2:
A computer-assisted assistance device acts as an intermediary between the practitioner and the measurement process. The device provides automated guidance on optimal catheter positioning and measurement locations based on pre-processed imaging data and computational fluid dynamics simulations, thereby standardizing the measurement process and improving reliability.
2Reliability
If multiple pressure measurements are performed at various positions to ensure complete functional characterization, then the completeness of measurement results improves, but the time and complexity of the procedure increase
Solution Approach 1:
The system pre-calculates the optimal set of measurement positions that will provide the most complete functional characterization with minimal measurements. By performing computational fluid dynamics simulations and stability analyses before the intervention, the system identifies exactly which positions need to be measured, avoiding unnecessary measurements and reducing procedure time.
Solution Approach 2:
The system replaces trial-and-error mechanical exploration with computer-based computational fluid dynamics simulations. The simulations predict which measurement positions will provide the most informative data for functional characterization, allowing practitioners to directly navigate to optimal positions rather than performing multiple exploratory measurements.
3Measurement precision
If computational fluid dynamics simulations are performed to determine optimal measurement positions, then the precision of position selection improves, but the computational complexity and processing time increase
Solution Approach 1:
The system replaces manual assessment of optimal measurement positions with automated computational fluid dynamics simulations. These simulations use the segmented vessel tree geometry to calculate flow patterns and identify positions where pressure measurements will be most stable and informative, thereby improving precision without requiring manual expertise.
Solution Approach 2:
The system creates a virtual copy of the patient's vessel tree from CT angiography data and performs simulations on this digital model. This virtual replica allows for extensive computational analysis without affecting the actual patient, enabling precise position determination through risk-free virtual experimentation.
4Measurement precision
If vessel tree segmentation from CT angiography is performed to enable overlay guidance, then the accuracy of catheter positioning improves, but the complexity of image processing and registration increases
Solution Approach 1:
The system introduces a virtual vessel tree overlay as an intermediary layer between the CT angiography images and the actual catheter navigation. This virtual overlay, generated through automated segmentation and registration algorithms, provides visual guidance to practitioners, improving positioning accuracy while encapsulating the complexity of image processing within the software system.
Data Source
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AI summary
The invention relates to an assistance device, an assistance system and an assistance method for assisting a practitioner in an interventional hemodynamic (e.g fractional flow reserve (FFR)) measurement on a subject. The FFR pressure measurements are combined with an, for example, angiography-based assessment of the coronary vessel geometry. An advanced computational fluid dynamics model may be employed to add flow and myocardial resistance data based on the interventional pressure values and on a vascular model generated prior to the intervention. In case that these data are available prior to the intervention, the location of most optimal positions for pressure measurements can be pre-calculated and by overlay of the vessel tree, for example, on the X-ray projection, advice can be given for the interventional cardiologist during the intervention.