Guidewire-Over Pressure Sensor Delivery for Accurate FFR Measurement
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Solution Overview
Problem
Existing methods for measuring physiological parameters, such as Fractional Flow Reserve (FFR), in blood vessels and heart valves are prone to errors due to catheter-induced blockage and leakage, require guidewire repositioning, and are hindered by physician preference for specific guidewire handling characteristics, making accurate diagnostic measurements time-consuming and difficult.
Innovation Solution
An intravascular sensor delivery device with a distal sleeve and guidewire lumen, allowing a sensor to be positioned accurately without repositioning the guidewire, and capable of simultaneous distal and proximal pressure measurements using a communication channel, facilitating accurate FFR calculations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a catheter is used to measure pressure gradient across a stenotic lesion, then pressure measurements can be obtained, but the catheter introduces additional flow obstruction that exaggerates the measured pressure gradient
Solution Approach 1:
The sensor delivery device is nested over an existing guidewire that has already been positioned across the stenotic lesion. This allows the sensor to be delivered to the measurement site without requiring a separate catheter to cross the lesion, thereby eliminating the additional flow obstruction that would be caused by a catheter while maintaining the ability to obtain accurate pressure measurements.
Solution Approach 2:
The guidewire serves as an intermediary tool that facilitates sensor delivery across the stenotic lesion without causing significant flow obstruction. By using the guidewire as the delivery medium rather than a catheter, the system achieves accurate pressure gradient measurements while minimizing the harmful effect of flow obstruction.
2Measurement precision
If a pressure sensing guidewire is used for measurements, then measurement capability is provided, but physicians resist using it due to unfamiliar torque and flexing characteristics
Solution Approach 1:
The system separates the measurement function from the guidewire itself. Instead of embedding sensors in the guidewire, the sensor is delivered on a separate delivery device that slides over the guidewire. This allows physicians to use their familiar guidewire for navigation while the sensor delivery device provides the measurement capability, combining the ease of operation of familiar guidewires with the measurement precision of pressure sensors.
3Measurement precision
If catheters are repositioned to obtain both distal and proximal pressure readings, then complete FFR measurement is achieved, but the process becomes cumbersome and time-consuming
Solution Approach 1:
The system combines multiple measurement capabilities into a single sensor delivery device. By integrating both distal and proximal pressure sensing capabilities on one device that remains stationary on the guidewire, the system eliminates the need to reposition catheters multiple times to obtain both pressure readings, thereby achieving complete FFR measurement while reducing the time and complexity of the procedure.
Data Source
AI summary
An intravascular sensor delivery device for measuring a physiological parameter of a patient, such as blood pressure, within a vascular structure or passage. In some embodiments, the device can be used to measure the pressure gradient across a stenotic lesion or heart valve. The sensor delivery device can be sized to pass over different sizes of guidewires to enable usage in coronary and peripheral arteries, for example.