Prosthetic Heart Valve Positional Markers for Radiographic Orientation

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Solution Overview

Problem

Current catheter-based methods for positioning prosthetic heart valves during minimally invasive procedures lack effective visualization techniques, making it difficult to ensure correct orientation and positioning relative to native heart valves, which can lead to patient complications due to the two-dimensional and radiographically non-distinguishable nature of existing imaging methods.

Innovation Solution

A prosthetic heart valve design featuring a valve assembly with a frame and control arms, where the control arms include positional markers that provide radiographic contrast and asymmetrical shapes or symbols to facilitate accurate alignment with native heart valves, allowing for rotational alignment verification through fluoroscopic imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If radiographic images are used for positioning the heart valve prosthesis, then the positioning can be achieved, but the images do not provide clear depth indication and device orientation information

Engineering Contradiction:
Improvepositioning accuracyVSAvoiddepth and orientation information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent applies radiopaque markers with varying radiopacity (analogous to color changes in visual terms) to provide depth and orientation information. The markers include a first marker with higher radiopacity and a second marker with lower radiopacity, allowing physicians to distinguish between different components and determine spatial relationships in the two-dimensional radiographic image.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent employs asymmetric positioning of radiopaque markers relative to the heart valve prosthesis structure. The markers are positioned at specific locations that create an asymmetric pattern, enabling physicians to determine the orientation and rotational position of the prosthesis by comparing the asymmetric marker arrangement against known reference configurations.

Inventive Principle:
Principle #4Asymmetry

2Ease of operation

If existing catheter-based delivery systems are used, then minimally invasive insertion is achieved, but visualization techniques cannot be effectively applied to verify correct positioning

Engineering Contradiction:
Improveminimally invasive insertionVSAvoidposition verification
Core Design Contradiction:
Ease of operationVSDifficulty of detecting and measuring

Solution Approach 1:

The patent introduces radiopaque markers as intermediary elements that mediate between the heart valve prosthesis and the radiographic imaging system. These markers serve as visual intermediaries that translate the three-dimensional positioning information into two-dimensional radiographic images, allowing physicians to verify positioning without compromising the minimally invasive nature of the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of information

If radiopaque markers are added to the heart valve prosthesis, then device orientation can be distinguished, but the device complexity increases

Engineering Contradiction:
Improvedevice orientation informationVSAvoidstructure complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent segments the radiopaque marking system into distinct, modular components including a first radiopaque marker and a second radiopaque marker with different radiopacity values. This segmentation allows each marker to serve a specific function (e.g., one for identifying the prosthesis location, another for indicating orientation), reducing the overall complexity compared to a single complex marking system.

Inventive Principle:
Principle #1Segmentation

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

The use of positional markers on control arms enhances the ability to correctly position and orient prosthetic heart valves relative to native valves, reducing the risk of complications by providing clear visual cues for precise alignment and orientation during minimally invasive procedures.

Implementation Method 1

The positional marker may be made of a material with a different radiopacity than other portions of the prosthetic heart valve

Methodology Applied
Scientific EffectRadiographic contrast: X-Ray

Data Source

PatentEP3019122B1Valve positioning device
Publication Date: 2024.05.29 MEDTRONIC INC
  • EP3019122B1 patent drawingFigure 1
  • EP3019122B1 patent drawingFigure 2
  • EP3019122B1 patent drawingFigure 3

AI summary

A prosthetic heart valve (100) includes a valve assembly (110), a frame (120), and a control arm (130). The prosthetic heart valve includes a commissural post (122) or multiple commissural posts. The prosthetic heart valve includes a positional marker (132) on a control arm. The prosthetic heart valve may include multiple positional markers on one or more control arms. The positional markers can be shapes, characters, or other symbols. The positional markers may themselves be asymmetric. The positional markers may be placed in an asymmetric location on a control arm. The control arm may be asymmetrically shaped.