Prosthetic Valve Diameter Estimation via Re-compression Assembly
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Solution Overview
Problem
During prosthetic valve implantation, there is a challenge in accurately monitoring the radial expansion diameter in real-time to ensure optimal sizing and prevent complications such as paravalvular leakage and annular rupture, particularly with mechanically expandable valves which require precise control over expansion.
Innovation Solution
A delivery assembly with a re-compression assembly that includes radiopaque markers and a diameter gauge, allowing for real-time monitoring of the prosthetic valve's expansion diameter through axial position indicators and visual feedback, enabling clinicians to adjust the expansion accordingly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If real-time monitoring of prosthetic valve expansion diameter is implemented, then manufacturing precision and reliability are improved, but device complexity increases due to additional monitoring components
Solution Approach 1:
The patent implements real-time feedback mechanisms through radiopaque markers visible during fluoroscopy and axial position indicators that provide continuous information about valve expansion diameter. This allows clinicians to monitor and adjust expansion in real-time, improving measurement precision while managing device complexity through intuitive visual feedback systems.
Solution Approach 2:
The patent replaces complex mechanical measurement systems with radiopaque markers that can be visualized through standard fluoroscopy equipment. This substitution eliminates the need for specialized mechanical sensors while achieving accurate real-time diameter measurement through optical/radiological detection methods.
2Measurement precision
If radiopaque markers and diameter gauge are added to the delivery assembly, then measurement precision is improved, but ease of operation deteriorates due to additional components
Solution Approach 1:
The patent merges the diameter measurement function directly into the delivery assembly structure, combining radiopaque markers, axial position indicators, and diameter gauge into an integrated system. This consolidation allows clinicians to obtain precise measurements without managing separate monitoring devices, thereby improving ease of operation while maintaining measurement precision.
3Adaptability or versatility
If mechanical actuation mechanism is used for valve expansion, then adaptability is improved for repositioning and readjustment, but reliability deteriorates due to risk of over-expansion and paravalvular leakage
Solution Approach 1:
The patent implements real-time feedback through radiopaque markers and axial position indicators that provide continuous information about valve expansion diameter during mechanical actuation. This feedback enables clinicians to monitor expansion closely and make precise adjustments, thereby maintaining adaptability for repositioning while improving reliability by preventing over-expansion and paravalvular leakage through controlled, monitored expansion processes.
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 control over prosthetic valve expansion, reducing the risk of complications like paravalvular leakage and annular rupture by providing real-time feedback on the valve's diameter, ensuring optimal implantation size and hemodynamic performance.
Implementation Method 1
The re-compression member comprises a loop portion configured to circumscribe the prosthetic valve, wherein the loop portion comprises at least one radiopaque marker
Data Source
AI summary
The present invention relates to devices, assemblies and methods for monitoring radial expansion of a prosthetic valve during prosthetic valve implantation procedures.