Prosthetic Valve Diameter Estimation During Real-Time Expansion

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Solution Overview

Problem

Existing prosthetic valve implantation procedures lack real-time monitoring of valve diameter expansion to ensure optimal sizing, risking paravalvular leakage or annular rupture due to mismatch between valve expansion diameter and surrounding tissue.

Innovation Solution

A method and system for estimating prosthetic valve diameters in real-time during expansion by analyzing structural components, such as strut segments and junctions, using image analysis to determine lateral widths and calculate outer diameters based on constant-length structural components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If real-time diameter monitoring is implemented during prosthetic valve expansion, then implantation precision and safety are improved, but device complexity and measurement difficulty increase

Engineering Contradiction:
Improveimplantation precisionVSAvoidmeasurement system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent uses fluoroscopic imaging to create a visual copy of the prosthetic valve structure during expansion. By capturing radiopaque markers and structural components in real-time images, the system creates a digital representation that can be analyzed to determine valve diameter without requiring direct physical measurement tools at the implantation site.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent replaces complex mechanical measurement devices with an optical/imaging-based system. Instead of using physical calipers or direct contact measurement tools during valve expansion, the system uses fluoroscopic images combined with image processing algorithms to calculate diameter, thereby reducing mechanical complexity while maintaining measurement capability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If real-time diameter monitoring is implemented during prosthetic valve expansion, then safety is improved by preventing paravalvular leakage and annular rupture, but loss of time increases due to image analysis processing

Engineering Contradiction:
ImprovesafetyVSAvoidprocessing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent incorporates radiopaque markers and structurally identifiable components into the prosthetic valve design before implantation. These pre-integrated features enable automated image recognition and diameter calculation during the expansion process, eliminating the need for post-implantation measurement and reducing real-time processing requirements.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides real-time feedback during valve expansion by continuously analyzing fluoroscopic images and calculating current diameter. This feedback loop allows operators to monitor expansion progress and make adjustments immediately, preventing both under-expansion (paravalvular leakage) and over-expansion (annular rupture) while maintaining efficient processing through automated calculation algorithms.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP4238053B1Systems and methods for estimating outer diameters of prosthetic valves
Publication Date: 2025.12.17 EDWARDS LIFESCIENCES CORP
  • EP4238053B1 patent drawingFigure 1~2
  • EP4238053B1 patent drawingFigure 3A~3C
  • EP4238053B1 patent drawingFigure 4A

AI summary

The present invention relates to systems and methods for estimating prosthetic valve expansion diameter, and in particular, for system and methods for analyzing images acquired during prosthetic valve expansion, to identify structural components of the valve, determine dimensions thereof, and estimate at least one outer diameter of the prosthetic valve, and potentially a plurality of outer diameter along different axial positions of the prosthetic valve.