IVUS Virtual Histology Device for Silent Clinical Event Detection
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Solution Overview
Problem
Current methods fail to effectively predict and prevent Clinical Events and Silent Clinical Events in patients with atherosclerosis, as they cannot accurately detect the risk based on physiological parameters such as Plaque Burden, Minimum Lumen Area, and the presence of VH-TCFA, due to limitations in resolution and detection capabilities.
Innovation Solution
A device and method using intravascular ultrasound (IVUS) combined with virtual histology (VH) to ascertain and evaluate physiological parameters like Plaque Burden, Minimum Lumen Area, and VH-TCFA presence, comparing these to target values to predict increased risk of Clinical or Silent Clinical Events, thereby alerting healthcare providers for proactive care.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If standard intravascular ultrasound (IVUS) imaging is used, then anatomical visualization is achieved, but detection precision of clinically silent events is insufficient
Solution Approach 1:
The patent combines standard IVUS anatomical imaging with virtual histology (VH) functional characterization into a single integrated imaging system. This merging allows simultaneous acquisition of both structural and compositional data, enabling detection of clinically silent events with higher precision without requiring separate imaging devices or procedures.
Solution Approach 2:
The patent adds a functional dimension to the traditional anatomical IVUS imaging by incorporating virtual histology analysis. This transforms the imaging capability from purely structural visualization to include tissue composition characterization, allowing detection of plaque vulnerability features that are not visible through anatomical imaging alone.
2Reliability
If multiple physiological parameters are evaluated, then prediction accuracy of clinical events is improved, but device complexity increases
Solution Approach 1:
The patent creates a multi-functional evaluation system that simultaneously assesses multiple physiological parameters including Plaque Burden, Minimum Lumen Area, and VH-TCFA presence within a single integrated platform. This universal system performs anatomical measurement, tissue characterization, and risk prediction functions concurrently, improving prediction accuracy while managing complexity through integration.
Solution Approach 2:
The patent performs preliminary evaluation of multiple physiological parameters during the initial IVUS imaging procedure. By pre-calculating Plaque Burden, Minimum Lumen Area, and detecting VH-TCFA lesions before clinical decision-making, the system provides comprehensive risk assessment data in advance, improving prediction accuracy without adding complexity to the clinical workflow.
3Difficulty of detecting and measuring
If resolution and detection capabilities are increased, then ability to detect VH-TCFA is improved, but measurement precision requirements increase
Solution Approach 1:
The patent introduces virtual histology (VH) analysis as an intermediary processing layer between raw IVUS signals and clinical interpretation. The VH algorithm acts as a mediator that automatically characterizes tissue composition and identifies VH-TCFA lesions, reducing the difficulty of detection while providing standardized, precise measurements that are less dependent on operator skill or imaging resolution limitations.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution enables healthcare providers to identify patients at higher risk for Clinical or Silent Clinical Events, allowing for timely preventative measures, thereby reducing the likelihood of adverse cardiovascular events.
Implementation Method 1
a transducer 122 is attached to the end of the catheter 120 and is carefully maneuvered through a patient's arteries to a point of interest along the artery. The transducer is then pulsed to acquire high-frequency sonic echoes or backscattered signals reflected from the tissue of the vascular object.
Data Source
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AI summary
Using a patient's physiological parameters ascertained using standard intravascular ultrasound (IVUS) in combination with virtual histology (VH), these physiological parameters are evaluated to predict whether the patients physiology has an increased risk of producing a Clinical Event or a Silent Clinical Event. In one embodiment the following three physiological parameters: the Plaque Burden; the Minimum Lumen Area; and whether a VH-TCFA or multiple VH-TCFAs are present are compared to target values and ranges. A concurrence of the values for the physiological parameters falling within the target ranges indicates that a patients physiology has an increased risk of producing a Clinical Event or a Silent Clinical Event, respectively. In other embodiments, combinations of any two of the three physiological parameters listed above are compared to target values and ranges. A concurrence of the values for two of the physiological parameters falling within the target ranges indicates that a patients physiology has an increased risk of producing a Clinical Event. In still other embodiments, any of the three physiological parameters listed above are compared to target values and ranges. Any of the values of the physiological parameters falling within the target ranges indicates that a patients physiology has an increased risk of producing a Clinical Event.