Radiopaque Markers for Transcatheter Valve Alignment

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Solution Overview

Problem

Current minimally invasive procedures for implanting prosthetic heart valves lack line-of-sight visualization, making it challenging to accurately position the valve due to the lack of visual cues, which can result in improper placement and function.

Innovation Solution

A delivery system utilizing alignment markers and implant markers that provide visual indications of the axial position and orientation of the prosthetic heart valve, allowing for precise alignment and orientation within the native heart valve using radiopaque materials visible in imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If radiographic imaging is used to guide prosthetic heart valve implantation, then the procedure can be performed minimally invasively, but the physician cannot see the actual orientation of the prosthetic heart valve during implantation

Engineering Contradiction:

Improveminimally invasive procedureVSAvoidvisual orientation information

Core Design Contradiction:

Ease of operationVSLoss of information

Solution Approach 1:

The patent applies radiopaque markers that appear as distinct visual indicators (such as bright spots or patterns) on radiographic images. These markers are attached to the prosthetic heart valve at specific locations to indicate axial and rotational orientation. When viewed on fluoroscopic or radiographic imaging, the markers provide real-time visual feedback about the valve's position and orientation, allowing the physician to see the actual orientation during implantation while maintaining the minimally invasive approach.

Inventive Principle:

Principle #32Color changes

2Ease of operation

If radiographic imaging is used to position the prosthetic heart valve, then the procedure is less invasive, but proper positioning is difficult to achieve accurately

Engineering Contradiction:

Improveminimally invasive procedureVSAvoidpositioning accuracy

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The radiopaque markers create high-contrast visual indicators on radiographic images, making it easy to distinguish the valve's position and orientation. The markers are strategically placed to provide clear visual cues about axial alignment and rotational orientation, enabling the physician to achieve accurate positioning by interpreting the two-dimensional image information with the aid of these visual references.

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The radiopaque markers serve as an intermediary between the prosthetic heart valve and the radiographic imaging system. They translate the physical position and orientation of the valve into visible visual indicators on the imaging screen, bridging the gap between the minimally invasive implantation approach and the need for accurate positioning feedback.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Manufacturing precision

If visual markers are added to the prosthetic heart valve to improve positioning accuracy, then positioning precision is improved, but the device complexity increases

Engineering Contradiction:

Improvepositioning accuracyVSAvoiddevice structure

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent uses radiopaque markers that appear as distinct visual indicators on radiographic images. These markers are attached to the prosthetic heart valve at specific locations to indicate axial and rotational orientation. When viewed on fluoroscopic or radiographic imaging, the markers provide real-time visual feedback about the valve's position and orientation, allowing the physician to see the actual orientation during implantation while maintaining the minimally invasive approach.

Inventive Principle:

Principle #32Color changes

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 accurate and precise positioning of the prosthetic heart valve, reducing the risk of migration and improper functioning by providing visual references for axial and rotational alignment during implantation.

Implementation Method 1

The combination of alignment markers and implant markers allow an operator of the delivery system to pinpoint the deployed location of the implantable medical device at the target site

Methodology Applied

Scientific EffectX-ray attenuation: Absorption (EM radiation)

Data Source

PatentUS20240407918A1Devices and methods for multi-alignment of implantable medical devices

Publication Date: 2024.12.12 MEDTRONIC INC

AI summary

A transcatheter valve prosthesis includes a stent having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes at least one axial frame member. The transcatheter valve prosthesis includes at least one outflow marker positioned on the at least one axial frame member. The transcatheter heart valve prosthesis may include inflow markers positioned within the inflow portion of the stent. The transcatheter heart valve prosthesis may include two outflow markers disposed on axial frame members, the two outflow markers being circumferentially and longitudinally offset from each other. The markers are configured to aid in axial and circumferential alignment of the transcatheter heart valve prosthesis within a native heart valve.