Aortic Valve Leaflet Severing for Transcatheter Replacement

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Solution Overview

Problem

Repeat replacement procedures for failing bioprosthetic aortic valves pose risks of coronary artery obstruction and complications for future percutaneous coronary interventions due to leaflet occlusion.

Innovation Solution

Devices and methods for preparing an existing transcatheter prosthetic aortic valve by severing and removing leaflets using various valve preparation devices, such as those with memory shape materials, articulation apparatus, and energy-carrying balloons, to facilitate subsequent prosthetic valve implantation while minimizing obstruction risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If repeat replacement procedures are performed for failing bioprosthetic aortic valves, then valve replacement is achieved, but coronary artery obstruction risks and future percutaneous coronary intervention difficulties increase

Engineering Contradiction:

Improvevalve replacement successVSAvoidcoronary artery obstruction risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by performing leaflet modification (severing, slitting, or detaching) before implanting the new prosthetic valve. This preparatory step creates coronary access pathways in advance, preventing obstruction issues that would otherwise arise after valve replacement. The leaflets are modified beforehand to ensure future coronary intervention accessibility while maintaining the benefits of repeat valve replacement.

Inventive Principle:

Principle #10Preliminary action

2Stability of the object's composition

If leaflets are left intact during repeat valve replacement, then valve structure is preserved, but coronary artery obstruction and intervention difficulty increase

Engineering Contradiction:

Improvevalve structure integrityVSAvoidcoronary intervention accessibility

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent applies segmentation by dividing the leaflet structure into separate regions - either severing leaflets from the stent frame, creating slits within leaflets, or detaching specific portions. This segmentation creates pathways for coronary access while preserving the overall valve structure and function. The leaflets are partially modified rather than completely removed, maintaining structural integrity while improving accessibility.

Inventive Principle:

Principle #1Segmentation

3Ease of operation

If aggressive leaflet removal is performed to eliminate obstruction risks, then coronary access is improved, but valve preparation complexity and potential complications increase

Engineering Contradiction:

Improvecoronary access easeVSAvoidvalve preparation complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The patent applies local quality by performing targeted modifications at specific locations on the leaflets rather than uniform removal. Different techniques are applied locally - severing at the stent interface, creating slits at specific depths, or detaching only portions of leaflets. This localized approach achieves coronary access improvement with controlled complexity and minimized risk compared to aggressive complete removal.

Inventive Principle:

Principle #3Local quality

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 solution effectively reduces the risk of coronary artery obstruction and facilitates future percutaneous coronary interventions by modifying the existing valve, allowing for safer and more accessible implantation of new prosthetic valves.

Implementation Method 1

The first portion and the second portion are each made of a memory shape material that is biased to bow outwardly with respect to central axis of the device

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 2

Either via engagement of the first and second portions or contact via electrodes, the first and second portions collectively sever the leaflet

Methodology Applied

Scientific EffectElectrical discharge cutting: Electric Arc

Data Source

PatentUS20240180697A1Devices and methods for aortic valve preparation prior to transcatheter prosthetic valve procedures

Publication Date: 2024.06.06 MEDTRONIC INC

AI summary

Aspects of the disclosure relate to devices and methods for preparing an existing, implanted prosthetic aortic valve for subsequent prosthetic aortic valve implantation. To prepare the existing valve, a valve preparation device is delivered to the valve and valve leaflets are severed either via mechanical cutting or electrodes so that the leaflets cannot obstruct a blood flow path once a prosthetic valve is subsequently implanted within the valve. Similarly, in alternate embodiments, devices and methods of the disclosure can be used for preparing a native aortic valve for delivery and implantation of a prosthetic valve.