Vessel Pressure Ratio Display for Hyperemia-Free Stenosis Assessment
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Solution Overview
Problem
Current methods for assessing the severity of stenosis in blood vessels, particularly coronary arteries, are hindered by the need for hyperemic agents like adenosine, which are costly, time-consuming, and contraindicated for certain patients, and do not accurately account for distal microcirculation fluctuations.
Innovation Solution
A system and method using two instruments, such as a guide wire and catheter, to obtain pressure measurements within a vessel, allowing for the calculation of a pressure ratio and visualization of pressure waveforms without hyperemic agents, by moving one instrument longitudinally while the other remains stationary, providing a graphical display of the pressure ratio and waveforms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hyperemic agents are administered to reduce vascular resistance for accurate 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
Solution Approach 1:
The patent extracts and removes the hyperemic agent administration step from the FFR measurement process. By using a single pressure-sensing catheter to measure pressures at both proximal and distal locations during normal physiological conditions, the method eliminates the need for adenosine or other vasodilator agents, thereby simplifying the overall measurement system while maintaining assessment capability
Solution Approach 2:
The patent introduces an intermediary computational approach by using pressure ratio calculations (Pd/Pa) during intermediate physiological states as a surrogate for true hyperemic FFR. This intermediary measurement, taken during normal or mildly stressed conditions, provides sufficient diagnostic information without requiring full hyperemic induction, thus reducing system complexity
2Reliability
If hyperemic agents are used to stabilize microcirculation resistance, then measurement reliability is improved, but loss of time increases due to drug preparation, administration, and stabilization periods
Solution Approach 1:
The patent performs preliminary pressure measurements during normal physiological conditions before any hyperemic agent administration is considered. By establishing baseline pressure ratios (iFR) during intermediate states, the method has preliminary data ready that may be sufficient for diagnosis, eliminating the need for time-consuming hyperemic induction and stabilization periods
Solution Approach 2:
The patent skips the traditional hyperemic induction and stabilization phase by directly measuring pressure ratios during normal or mildly stressed conditions. This rushing through the intermediate measurement stage provides sufficient diagnostic information in a fraction of the time required for full hyperemic FFR, reducing procedural duration while maintaining clinical utility
3Measurement precision
If hyperemic agents are administered multiple times to obtain FFR measurements, then measurement precision is improved, but object-generated harmful factors increase due to patient discomfort and contraindications
Solution Approach 1:
The patent uses a single, simple pressure-sensing catheter that can be used for multiple measurements without requiring repeated hyperemic agent administrations. This disposable-like approach with a single measurement tool eliminates the cumulative harmful effects of multiple drug exposures while maintaining the ability to obtain sufficient diagnostic data
Solution Approach 2:
The patent allows the patient's own physiological system to provide the measurement conditions by utilizing normal or mildly stressed states rather than requiring external pharmacological intervention. The body's natural pressure fluctuations during intermediate physiological states serve the measurement purpose, eliminating the need for hyperemic agents and their associated discomfort and contraindications
4Reliability
If central venous access is obtained for hyperemic agent administration, then measurement reliability is improved, but ease of operation deteriorates due to additional invasive procedures
Solution Approach 1:
The patent extracts and removes the central venous access requirement from the FFR measurement process. By using a standard pressure-sensing catheter that can be introduced through peripheral access and utilizing pressure ratio measurements during normal physiological conditions, the method eliminates the need for complex central line placement while maintaining measurement capability through alternative physiological pathways
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.