Wireless Intravascular Pressure Sensor for Stenosis Assessment
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Solution Overview
Problem
Current methods for assessing the severity of a stenosis in blood vessels, such as fractional flow reserve (FFR), require pharmacological hyperemic agents that are costly, time-consuming, and not suitable for all patients, and existing pressure measurement devices are large, cumbersome, and often fail to provide reliable aortic pressure signals, leading to inaccurate diagnoses.
Innovation Solution
A compact, wireless pressure measurement system that integrates with existing proximal and distal pressure measurement devices, eliminating the need for separate power sources and allowing for reliable, wireless transmission of pressure signals to computing systems, enabling accurate assessment of stenosis severity without hyperemic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pharmacological hyperemic agents are administered to reduce vascular resistance for accurate FFR measurement, then measurement precision is improved, but loss of time and loss of substance increase due to preparation time and cost
Solution Approach 1:
The system performs preliminary calibration by establishing a relationship between distal pressure and aortic pressure during a calibration period before actual FFR measurement. This preliminary action eliminates the need for hyperemic agents during the measurement phase, reducing time loss while maintaining measurement precision through pre-established calibration data
Solution Approach 2:
The invention extracts the requirement for hyperemic agents from the FFR measurement process by using an alternative method that relies on pressure sensor calibration and mathematical relationships between pressure measurements. This removes the harmful factor of drug administration time and cost while preserving the essential function of accurate stenosis assessment
2Measurement precision
If large expensive hemodynamic systems are used to provide high level analog voltage output for FFR calculation, then measurement precision is improved, but device complexity and cost increase
Solution Approach 1:
The system combines the distal pressure sensor, aortic pressure sensor, signal processing electronics, and FFR calculation capabilities into an integrated device. This merging eliminates the need for separate large expensive hemodynamic systems while maintaining measurement precision through coordinated operation of integrated components
Solution Approach 2:
The distal pressure sensing device serves multiple functions: it measures distal pressure, provides calibration data for aortic pressure correlation, and enables FFR calculation without requiring dedicated high-level output equipment. This multi-functionality reduces device complexity while maintaining measurement precision across different operational modes
3Measurement precision
If multiple devices are connected to obtain both distal and aortic pressure measurements for FFR calculation, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The system merges the distal pressure sensing device with the aortic pressure sensing capability into a coordinated integrated system. This combination maintains the dual pressure measurement functionality needed for FFR calculation while reducing the number of separate connected devices and simplifying the overall system architecture
Solution Approach 2:
The distal pressure sensing device acts as an intermediary that captures both distal pressure and correlated aortic pressure information, eliminating the need for separate aortic pressure measurement devices. This intermediary function maintains measurement precision while reducing device complexity by consolidating measurement capabilities
Data Source
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AI summary
Embodiments of the present disclosure are configured to assess the severity of a blockage in a vessel and, in particular, a stenosis in a blood vessel. In some particular embodiments, the devices, systems, and methods of the present disclosure are configured to collect and wirelessly distribute reliable pressure signals to other devices, and do so in a small, compact device that integrates with existing proximal and distal pressure measurement systems and does not require a separate power source.