Dual-Sensor Catheter for Accurate FFR Measurement
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Solution Overview
Problem
Current methods for obtaining vascular pressure measurements for calculating Fractional Flow Reserve (FFR) values are limited by the inability to accurately assess stenosis severity due to fluctuations in vascular resistance, necessitating the use of pharmacological agents like adenosine to stabilize resistance, and there is a need for alternative devices and methods for effective pressure measurement.
Innovation Solution
A catheter design featuring an outer component with a side opening and an inner component with a guidewire lumen, allowing for relative longitudinal translation of pressure sensors to vary the distance between them, enabling precise pressure measurements at a vascular lesion, with a first pressure sensor at the distal end of the outer component and a second at the distal end of the inner component.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a single pressure sensor is used to measure distal pressure, then the measurement is simple to obtain, but it cannot accurately assess stenosis severity due to pressure fluctuations from proximal and distal vascular resistance
Solution Approach 1:
The catheter is divided into outer and inner components with separate pressure sensors positioned at different locations. The outer component has a pressure sensor for proximal pressure measurement, while the inner component has a pressure sensor for distal pressure measurement. This segmentation allows simultaneous measurement of pressures at different vascular locations to accurately assess stenosis severity.
Solution Approach 2:
The inner component with its pressure sensor is nested within the lumen of the outer component. The inner component can be longitudinally translated relative to the outer component, allowing the distal pressure sensor to be positioned at the tip while the proximal pressure sensor remains in the outer component. This nested structure enables dual pressure measurement within a single catheter device.
2Stability of the object's composition
If pharmacological agents like adenosine are administered to reduce vascular resistance, then pressure measurements become more stable, but the treatment requires additional medications and increases procedural complexity
Solution Approach 1:
The patent replaces the pharmacological approach (chemical method) with a mechanical measurement approach. Instead of using adenosine to chemically reduce vascular resistance, the device uses a mechanical dual-sensor system to simultaneously measure proximal and distal pressures, allowing direct calculation of pressure gradient and stenosis severity without requiring vascular resistance modification.
3Adaptability or versatility
If the distance between pressure sensors is fixed, then the device structure is simpler, but it cannot adapt to different lesion locations and depths
Solution Approach 1:
The inner component is designed to be longitudinally translatable relative to the outer component, creating a dynamic positioning system. This allows the distance between the proximal pressure sensor (in the outer component) and the distal pressure sensor (in the inner component) to be adjusted based on the specific lesion location and depth, providing adaptability to different measurement requirements.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This design allows for accurate and stable pressure measurements, reducing the need for pharmacological agents and enhancing the precision of FFR calculations by enabling simultaneous proximal and distal pressure measurements, facilitating effective assessment of stenosis severity.
Implementation Method 1
a first pressure sensor is disposed proximate of a distal end of the outer component and a second pressure sensor is disposed proximate of a distal end of the inner component
Data Source
AI summary
A catheter is disclosed for providing pressure measurements at a vascular lesion. The catheter includes an outer component having a side opening the providing transverse access to a lumen thereof and an inner component slidably disposed within the lumen. The inner component has a guidewire lumen with a proximal side port. When the inner component is longitudinally translated relative to the outer component, the side port of the inner component is accessible through the side opening of the outer component for providing transverse access to a guidewire. A first pressure sensor is disposed proximate of a distal end of the outer component and a second pressure sensor is disposed proximate of a distal end of the inner component, such that relative longitudinal translation between the inner and outer components permits a distance between the first and second pressure sensors to be varied.