Prosthetic Valve Frame Markers for Even Radial Expansion

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Solution Overview

Problem

There is a need for improved transcatheter prosthetic devices that can expand evenly and be monitored in real-time during radial expansion, particularly for mechanically expandable prosthetic heart valves.

Innovation Solution

The use of a radially compressible and expandable frame with movable markers and screw actuators to monitor and control the evenness of radial expansion, allowing for real-time monitoring under fluoroscopy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If real-time monitoring of radial expansion is implemented, then deployment precision is improved, but device complexity increases

Engineering Contradiction:
Improvedeployment precisionVSAvoiddevice complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent employs radiopaque markers that appear as distinct radiodense structures under fluoroscopic imaging, enabling visual monitoring of frame expansion. These markers are integrated into the frame structure at strategic locations, allowing operators to track radial expansion in real-time without adding complex electronic sensing systems.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent uses fluoroscopic imaging as an intermediary tool to monitor frame expansion. The radiopaque markers serve as intermediaries between the mechanical expansion process and the operator's visual assessment, translating physical dimensional changes into observable radiographic signals without requiring direct electronic sensors in the device.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If mechanical actuators are used for expansion, then adaptability is improved, but device complexity increases

Engineering Contradiction:
ImproveadaptabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The frame is divided into multiple expandable cells or segments, each with its own radiopaque markers. This segmentation allows independent monitoring and control of different portions of the frame, enabling adaptive adjustment during deployment while maintaining a modular structure that manages complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mechanical actuator system provides dynamic control over frame expansion, allowing the operator to adjust the expansion process in real-time based on fluoroscopic feedback. The system transitions from a static deployed state to a dynamically controllable process, enhancing adaptability while using straightforward mechanical components.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP4447863B1Apparatus for monitoring radial expansion of prosthetic device
Publication Date: 2025.12.17 EDWARDS LIFESCIENCES CORP
  • EP4447863B1 patent drawingFigure 1A
  • EP4447863B1 patent drawingFigure 1B
  • EP4447863B1 patent drawingFigure 2A

AI summary

Certain examples of the disclosure concern a prosthetic device. The prosthetic device can include a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to be rotated to radially expand the frame from a radially compressed state to a radially expanded state. The frame can include two or more pairs of first markers and second markers. The pairs of first and second markers can be circumferentially spaced apart from each other. The first and second markers of each pair can be axially aligned and axially movable relative to one another as the frame radially expands. Positions of the first and second markers can be configured so that a difference in axial distances between respective pairs of the first markers and second markers can indicate a degree of evenness of the frame's radial expansion.