Coronary Pressure Pullback Display for Hyperemia-Free Stenosis Assessment
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Solution Overview
Problem
Current methods for assessing the severity of coronary stenosis, such as fractional flow reserve (FFR), require the administration of hyperemic agents like adenosine, which can be costly, time-consuming, and contraindicated for certain patients, making them inconvenient and less reliable.
Innovation Solution
A system and method using two instruments positioned within a vessel to obtain pressure measurements, one stationary and one moved longitudinally, providing a visual representation of pressure ratios and waveforms on a display without the need for hyperemic agents, allowing assessment of stenosis severity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hyperemic agents like adenosine are administered to reduce vascular resistance for FFR measurement, then measurement precision is improved, but device complexity and ease of operation deteriorate due to the need for additional drugs, administration protocols, and monitoring procedures
Solution Approach 1:
The patent extracts and eliminates the hyperemic agent administration step from the FFR measurement process. By using a pullback technique that measures pressure gradients while withdrawing the catheter through the stenosis, the method obtains accurate stenosis assessment without requiring vasodilator drugs, thereby simplifying the procedure while maintaining measurement precision
Solution Approach 2:
The measurement process is segmented into multiple positional measurements during catheter withdrawal. By taking pressure measurements at different positions (proximal, at stenosis, distal) during the pullback sequence, the system captures the pressure gradient across the stenosis without needing hyperemic agents, resolving the contradiction between accuracy and procedural simplicity
2Reliability
If hyperemic agents are administered to stabilize microcirculation resistance, then reliability of FFR measurement is improved, but loss of time increases due to drug preparation, administration, and stabilization periods
Solution Approach 1:
The patent performs the pressure measurements during the catheter pullback sequence itself, capturing the pressure gradient at the moment of withdrawal. This preliminary action during the necessary procedural step eliminates the need for separate drug administration and stabilization time, maintaining measurement reliability while reducing total procedure time
Solution Approach 2:
The method skips the time-consuming hyperemic agent administration and stabilization phase by rapidly performing the pressure gradient measurement during catheter withdrawal. The pullback technique allows the system to rush through the measurement process in a single continuous action, achieving reliable FFR values without the time loss associated with pharmacological preparation
3Measurement precision
If hyperemic agents are used to reduce microcirculation resistance, then measurement accuracy is improved, but object-affected harmful factors increase due to patient contraindications and adverse reactions
Solution Approach 1:
The patent converts the potential harm of hyperemic agent administration into benefit by using the natural pressure gradient that exists during catheter withdrawal. Instead of forcing vasodilation with drugs that may harm certain patients, the method utilizes the mechanical action of pullback to create measurable pressure differences, achieving accurate stenosis assessment while eliminating drug-related safety risks
Solution Approach 2:
The catheter pullback mechanism serves as an intermediary that replaces the hyperemic agent as the means to generate measurable pressure gradients. By using the mechanical withdrawal process as the mediator between the measurement system and the patient's vasculature, the method achieves the same measurement goal without introducing harmful pharmacological substances
Data Source
AI summary
Devices, systems, and methods for visually depicting a vessel and evaluating treatment options are disclosed. The methods can include obtaining pressure measurements from first and second instruments positioned within a vessel of a patient while the second instrument is moved longitudinally through the vessel from a first position to a second position and the first instrument remains stationary within the vessel; and outputting a visual representation of the pressure measurements obtained by the first and second instruments on a display, the output visual representation including a graphical display of a pressure ratio of the obtained pressure measurements and at least a portion of a pressure waveform of the obtained pressure measurements identifying a diagnostic period utilized in calculating the pressure ratio.


