Radiopaque Marker Tracking for Prosthetic Valve Expansion

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Solution Overview

Problem

There is a need for improved transcatheter heart valves and delivery devices that can accurately monitor and control the radial expansion of prosthetic valves during implantation, as existing technologies lack effective methods for real-time size monitoring and locking mechanisms.

Innovation Solution

A delivery apparatus with radiopaque markers is used to provide visual feedback on the radial expansion of prosthetic valves, allowing for precise diameter measurement and locking, featuring a first and second portion that maintain fixed spatial relationships with the valve ends, and includes an expansion mechanism with locking capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If percutaneous valve implantation is performed, then minimally invasive approach is achieved, but real-time monitoring of valve expansion is not possible

Engineering Contradiction:
Improveminimally invasive approachVSAvoidvalve expansion monitoring
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

Radiopaque markers are introduced as intermediary elements on the delivery apparatus and valve frame to enable visualization and measurement of valve expansion during percutaneous implantation. These markers serve as mediators between the minimally invasive procedure and the need for precise real-time monitoring.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces complex electronic sensing systems with a simpler radiographic imaging system using radiopaque markers. This substitution enables real-time monitoring during percutaneous implantation by leveraging existing fluoroscopy infrastructure, making the monitoring feasible within the minimally invasive approach.

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

2Measurement precision

If valve expansion is monitored in real-time, then accurate sizing is achieved, but device complexity increases

Engineering Contradiction:
Improvevalve diameter measurementVSAvoiddelivery apparatus structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The delivery apparatus is segmented into distinct functional components with radiopaque markers placed at specific locations. The first and second portions of the delivery apparatus are separated, with the first portion containing reference markers and the second portion containing indicator markers. This segmentation allows for simplified real-time monitoring while maintaining measurement precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses radiopaque markers that appear as distinct visual indicators under fluoroscopy, similar to using color changes for indication. These markers provide clear visual feedback on valve expansion without adding complex electronic displays or sensors, thus maintaining device simplicity while achieving accurate measurement.

Inventive Principle:
Principle #32Color changes

3Stability of the object's composition

If locking mechanism is added to control valve diameter, then valve stability is improved, but device complexity increases

Engineering Contradiction:
Improvevalve diameter stabilityVSAvoidexpansion mechanism
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The locking mechanism is designed to work in conjunction with the existing delivery apparatus components. The first and second portions of the delivery apparatus can be detached and reattached to engage and disengage the locking mechanism, allowing the system to lock the valve diameter using readily available components rather than requiring a completely separate locking system.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The locking mechanism provides dynamic control over valve expansion, allowing the valve to transition between expanded and compressed states. The ability to detach and reattach the first and second portions enables the system to adapt between locked and unlocked states, providing necessary stability while maintaining operational flexibility.

Inventive Principle:
Principle #15Dynamics

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 real-time monitoring and control of prosthetic valve expansion, ensuring accurate sizing and locking, thereby enhancing the implantation process of transcatheter heart valves.

Implementation Method 1

The first portion can include one or more reference radiopaque markers and the second portion can include an indicator radiopaque marker

Methodology Applied
Scientific EffectX-ray reflection: Reflection

Data Source

PatentUS20250387226A1Apparatus and method for monitoring valve expansion
Publication Date: 2025.12.25 EDWARDS LIFESCIENCES CORP
  • US20250387226A1 patent drawing
  • US20250387226A1 patent drawing
  • US20250387226A1 patent drawing

AI summary

Embodiments of a prosthetic valve delivery apparatus are disclosed. The delivery apparatus includes a first portion configured to maintain a fixed spatial relationship relative to a first end of the prosthetic valve and a second portion configured to maintain a fixed spatial relationship relative to a second end of the prosthetic valve during radial expansion of the prosthetic valve. The first portion includes one or more reference radiopaque markers and the second portion includes an indicator radiopaque marker. A position of the indicator radiopaque marker relative to the one or more reference radiopaque markers measures an axial distance between the first and second ends of the prosthetic valve indicative of a corresponding diameter of the prosthetic valve as it is radially expanded from a radially compressed state to a radially expanded state.