Bedside Pressure Controller 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 are costly, time-consuming, and not suitable for all patients, leading to inefficiencies and potential miscommunication during procedures.
Innovation Solution
A bedside controller with a touch-sensitive display is used to analyze pressure measurements from instruments within a vessel, allowing clinicians to assess stenosis severity directly and visually without hyperemic agents, through a touch-enabled interface that integrates data processing and display.
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 procedural time increases and costs increase
Solution Approach 1:
The patent extracts the essential measurement function (pressure ratio assessment) from the complex FFR protocol requiring hyperemic agents. By using a single pressure sensor that measures pressure ratios during normal physiological conditions without pharmacological intervention, the system eliminates the time-consuming administration and monitoring of hyperemic agents while retaining the core capability to assess stenosis severity
Solution Approach 2:
The patent employs a single-use, disposable pressure sensor that can be quickly inserted and removed from the vessel. This disposable sensor eliminates the need for expensive, reusable equipment and complex calibration procedures, thereby reducing both procedural time and costs while maintaining measurement accuracy for stenosis assessment
2Reliability
If multiple clinicians are involved in the procedure with separate roles, then specialized tasks can be performed, but miscommunication errors increase and procedural efficiency decreases
Solution Approach 1:
The patent merges the functions of multiple clinicians into a single integrated system. The bedside controller consolidates data acquisition, real-time pressure ratio calculation, waveform display, and assessment guidance that were previously distributed among multiple clinicians. This integration eliminates communication gaps and ensures all information is accurately transmitted and interpreted
Solution Approach 2:
The system provides real-time visual feedback through waveforms and numerical pressure ratio values displayed on the bedside controller. This immediate feedback loop allows the operator to continuously monitor assessment quality and make adjustments as needed, ensuring reliable results without requiring multiple clinicians to verify each other's work
3Measurement precision
If hyperemic agents are administered to reduce vascular resistance, then FFR calculation accuracy improves, but patient eligibility decreases and procedural complexity increases
Solution Approach 1:
The patent changes the measurement parameters from requiring pharmacologically-induced hyperemia to utilizing normal physiological pressure fluctuations. By measuring pressure ratios during baseline conditions without altering vascular resistance through drug administration, the system expands patient eligibility to include those who cannot receive hyperemic agents while maintaining sufficient accuracy for clinical decision-making
Data Source
AI summary
Devices, systems, and methods for evaluating a vessel of a patient are provided. The method includes outputting, to a touch-sensitive display of a bedside controller, a screen display including: a visual representation of a first pressure ratio of pressure measurements obtained by first and second instruments positioned within a vessel while the second instrument is moved from a distal position to a proximal position relative a stenosis and the first instrument remains stationary; and a first proximal pressure waveform and a first distal pressure waveform; receiving, through the touch-sensitive display of the bedside controller, a user touch input on the first proximal pressure waveform and/or the first distal pressure waveform identifying a time at which pressure measurements were obtained; and modifying the screen display, in response to the user touch input, to further include a visual representation of the obtained pressure measurements corresponding to the identified time.