Dual Lumen Catheter Handle-Mounted Pressure Sensor
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Solution Overview
Problem
Current methods for obtaining distal pressure measurements for calculating Fractional Flow Reserve (FFR) values in vascular lesions are inadequate 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 accurate pressure measurement.
Innovation Solution
A catheter with a handle component and an elongate tubular shaft that includes a blood pressure lumen and a guidewire lumen, allowing blood to fill through sidewall windows to position a pressure sensor at the distal end for accurate pressure measurement, enabling the calculation of FFR values without the need for external sensors or wires.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a sensor is placed on the distal portion of a flexible interventional device to obtain distal pressure measurement, then the measurement can be obtained, but the device complexity increases and manufacturing costs increase
Solution Approach 1:
The patent combines the pressure sensor with the handle component of the catheter system, merging two previously separate functions (handle operation and pressure sensing) into a single integrated unit. This eliminates the need for separate distal sensors and their associated wiring, thereby reducing device complexity while maintaining measurement capability
Solution Approach 2:
The patent introduces a fluid communication pathway (lumen system) as an intermediary to transmit pressure information from the distal measurement site to the proximal sensor location. This allows the sensor to remain in the handle component while still measuring distal pressure, avoiding the need to place electronics at the distal tip
2Measurement precision
If a sensor is placed on the distal portion of a flexible interventional device to obtain distal pressure measurement, then the measurement can be obtained, but manufacturing costs increase
Solution Approach 1:
By merging the pressure sensor into the handle component, the patent reduces the number of separate parts that need to be manufactured and assembled. This integration eliminates the need for distal sensor housing, distal wiring, and complex sealing arrangements, thereby reducing manufacturing costs
Solution Approach 2:
The patent extracts the sensor from the distal portion of the catheter and relocates it to the handle component. This extraction simplifies the distal catheter structure and reduces the complexity of assembling and testing the complete system, leading to lower manufacturing costs
3Measurement precision
If external pressure transducer is fluidly connected via tubing to guide catheter for obtaining proximal pressure measurement, then the measurement can be obtained, but the device complexity increases
Solution Approach 1:
The patent merges both proximal and distal pressure sensing capabilities into the handle component, eliminating the need for external pressure transducers and tubing connections. This integration simplifies the overall system architecture by consolidating all pressure measurement functions in one location
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
The catheter provides stable and accurate pressure measurements at vascular lesions, simplifying the calculation of FFR values and reducing manufacturing costs by housing the pressure sensor within the handle component, allowing for a wider variety of sensors to be used and eliminating the need for electrical connections.
Implementation Method 1
The blood pressure lumen provides fluid communication between the pressure sensor within the handle component at the proximal end of the tubular shaft and a plurality of sidewall windows at the distal end of the tubular shaft
Implementation Method 2
the pressure sensor is able to sense a pressure of the blood at the distal end of the tubular shaft
Data Source
AI summary
A catheter is disclosed for providing a pressure measurement at a vascular lesion. The catheter includes a tubular component having dual lumens along at least a segment thereof in which a first lumen acts as a pressure inlet and a second lumen allows the catheter to be tracked over a guidewire. A plurality of openings are located along a distal segment of the tubular component that permit blood flow into the first lumen when disposed in vivo. A pressure sensor is located within a handle component of the catheter or within the tubular component to be in fluid communication with a proximal end of the first lumen. When the catheter is positioned at the vascular lesion, the first lumen fills with blood via the plurality of openings such that the pressure sensor is able to sense a pressure of the blood at a distal end of the catheter.