Frangible Expansion Belt for Prosthetic Valve Force Monitoring
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Solution Overview
Problem
Existing methods for measuring the diameter and radial force of mechanically expandable prosthetic heart valves during implantation fail to accurately account for factors such as compression of the delivery device and elongation of the actuation mechanism, risking damage to the native heart valve annulus.
Innovation Solution
The use of a belt with frangible members that break at predetermined thresholds to control the radial expansion of prosthetic devices, allowing real-time monitoring of diameter and force exerted on the native anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If measurement methods rely on measuring the displacement of an actuation mechanism, then the diameter and radial force can be monitored during deployment, but the measurements fail to account for compression of the delivery device and elongation of the actuation mechanism under tension, resulting in inaccurate measurements
Solution Approach 1:
A belt is introduced as an intermediary element between the prosthetic valve and the delivery system. The belt remains relatively stationary during deployment while the delivery device and actuation mechanism move, allowing accurate measurement of valve diameter and radial force without being affected by compression or elongation of the actuation mechanism.
Solution Approach 2:
The patent replaces displacement measurement of the actuation mechanism with direct measurement of the belt's dimensional changes. By measuring the belt's circumference or diameter directly (rather than inferring from actuator displacement), the system achieves accurate measurements independent of actuation mechanism deformation.
2Productivity
If the prosthetic valve is expanded to larger diameters, then the valve provides better functional performance, but excessive radial force can rupture the native heart valve annulus
Solution Approach 1:
The belt provides real-time feedback on the radial force being applied to the native annulus through measurements of dimensional changes. This feedback allows the operator to monitor the expansion process and stop before exceeding the safe force threshold that would cause annular rupture, while still achieving optimal valve expansion for functional performance.
Data Source
Figure 1
Figure 2A~2B
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AI summary
A belt for an implantable prosthetic device can include an annular body including a plurality of alternating peaks and valleys and a plurality of frangible members extending between at least one of adjacent peaks and adjacent valleys. The annular body can be radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via an expandable implantable prosthetic device. A first frangible member of the plurality of frangible members can be configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular body to a second diameter.