Flex Sensor Valve Sizing for Real-Time Prosthetic Valve Expansion
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Solution Overview
Problem
Existing prosthetic valve implantation procedures lack real-time monitoring of expansion diameter, leading to potential paravalvular leakage and hemodynamic issues due to mismatch between valve expansion diameter and surrounding tissue.
Innovation Solution
A delivery assembly equipped with flex sensors coupled to prosthetic valve struts, generating signals for real-time diameter measurement, and a control unit to adjust expansion, ensuring optimal implantation size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If real-time diameter monitoring is implemented during valve implantation, then implantation precision and valve sizing accuracy are improved, but device complexity increases due to addition of flex sensors and control systems
Solution Approach 1:
The patent replaces complex mechanical measurement systems with flex sensors that utilize flexoelectric or piezoelectric effects. These sensors convert mechanical deformation of the valve frame directly into electrical signals, providing real-time diameter measurements without requiring complex mechanical gauges or imaging systems.
Solution Approach 2:
The flex sensors act as intermediaries between the valve frame structure and the control system. They are coupled to the struts of the valve frame and translate physical expansion/contraction into measurable electrical signals that the control unit can process to determine valve diameter.
2Measurement precision
If flex sensors are coupled to valve struts for real-time measurement, then measurement capability is improved, but structural complexity of the valve assembly increases
Solution Approach 1:
The patent merges the measurement function with the existing valve structure by coupling flex sensors directly to the valve struts. This integration allows the sensors to utilize the natural expansion and contraction movements of the valve frame during implantation, eliminating the need for separate measurement mechanisms.
Solution Approach 2:
The flex sensors serve multiple functions: they measure valve diameter, monitor expansion progress, and provide feedback for control system adjustment. This multi-functionality reduces the need for additional dedicated components for each measurement task.
3Manufacturing precision
If control unit adjusts valve expansion based on real-time feedback, then implantation accuracy is improved, but procedural time increases due to continuous monitoring and adjustment cycles
Solution Approach 1:
The patent implements a closed-loop feedback system where flex sensors continuously monitor valve diameter and provide real-time signals to the control unit. The control unit processes this information and automatically adjusts the expansion mechanism to achieve the target diameter, enabling precise control without requiring multiple manual measurement and adjustment iterations.
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
Enables precise monitoring and adjustment of prosthetic valve expansion, minimizing leakage and hemodynamic complications by ensuring proper valve sizing during implantation.
Implementation Method 1
at least one flex sensor coupled to at least one of the plurality of struts
Data Source
AI summary
A delivery assembly constituted of: a prosthetic valve comprising a plurality of intersecting struts, and a delivery apparatus comprising: a handle; a delivery shaft extending distally from the handle; and a flex sensing assembly, comprising: at least one flex sensor coupled to at least one of the plurality of struts; and a control unit in communication with the at least one flex sensor, wherein the prosthetic valve is movable between a radially compressed configuration and a radially expanded configuration, and wherein, responsive to an output of the at least one flex sensor, the control unit is configured to generate a signal indicative of a diameter of the prosthetic valve.