Bedside PCI Interface for Hyperemia-Free Stenosis Assessment
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Solution Overview
Problem
Current methods for assessing the severity of stenosis in blood vessels, such as fractional flow reserve (FFR), are hindered by the need for hyperemic agents like adenosine, which are costly, time-consuming, and not suitable for all patients, leading to inefficiencies and potential miscommunication during PCI planning.
Innovation Solution
A bedside interface with touch-sensitive display technology integrates pressure measurements from multiple instruments to provide real-time, high-magnification visualizations of vessel blockages, allowing for simulation and comparison of treatment options like angioplasty and stenting, without the need for hyperemic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fractional flow reserve (FFR) assessment is performed using traditional methods with hyperemic agents, then stenosis severity can be assessed, but procedure time increases and costs increase
Solution Approach 1:
The patent extracts the essential measurement function (pressure differential assessment) from the complex FFR protocol requiring hyperemic agents. By using a simple pressure wire that measures pressure differential without requiring adenosine or other vasodilators, the system removes the time-consuming pharmacological induction and monitoring steps while retaining the core diagnostic capability of assessing stenosis severity through pressure ratios
Solution Approach 2:
The patent employs a single-use pressure wire that is discarded after one procedure, eliminating the need for expensive, time-consuming hyperemic agents like adenosine. The disposable nature of the pressure wire simplifies the procedure by removing pharmacological preparation and recovery time, while the low cost of the single-use device offsets the elimination of expensive drug administration protocols
2Measurement precision
If multiple clinicians are involved in data acquisition and analysis, then comprehensive assessment is achieved, but communication errors increase and procedure complexity increases
Solution Approach 1:
The patent merges the functions of data acquisition, real-time visualization, and diagnostic decision-making into a single integrated system. The pressure wire connects directly to a display system that shows pressure differential and FFR calculations in real-time, allowing the interventionalist to perform all functions alone without requiring separate clinicians for data collection, analysis, and interpretation, thereby eliminating communication errors while maintaining comprehensive assessment
Solution Approach 2:
The system enables the interventionalist to independently perform the complete FFR assessment workflow. The pressure wire automatically measures pressure differential, the system calculates FFR values, and the display presents results in real-time, allowing the operator to self-assess stenosis severity without requiring assistance from other clinicians, thus simplifying the workflow while maintaining diagnostic accuracy
3Device complexity
If static displays are used in the sterile field, then equipment simplicity is maintained, but physician efficiency decreases
Solution Approach 1:
The patent replaces static display screens with a dynamic, real-time visualization system that continuously updates pressure differential measurements and FFR calculations as the pressure wire is moved through the vasculature. This dynamic display allows the physician to immediately see changing pressure gradients and identify significant stenoses during the procedure, dramatically improving efficiency by eliminating the need to review multiple static images after the procedure
Data Source
AI summary
Devices, systems, and methods configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel, provide measurements of a vessel that allow assessment of the vessel and, in particular, any stenosis or lesion of the vessel, simulate diagnostic visualizations a first visualization device and a second visualization device. For example, the methods can include displaying, on a first visualization device, an image of the vessel with treatment diagnostic visualizations based on obtained pressure measurements and displaying, on a second visualization device, a portion of the image of the vessel with diagnostic visualizations based on the obtained pressure measurements, wherein the portion of the image of the vessel displayed on the second visualization device is a close up of a region of interest of the vessel.