Conductive Electrode Perforation Assembly for TAVR Leaflet Modification

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Solution Overview

Problem

Existing methods for mitigating coronary ostial obstruction during transcatheter aortic valve replacement (TAVR) require high spatial precision and surgical skill, and can lead to aortic insufficiency and vascular occlusion risks, especially when lacerating calcified leaflets.

Innovation Solution

A perforation assembly with a delivery apparatus and an electrode that extends distally to create precise perforations in valvular leaflets using an electric current, allowing for controlled modification of leaflets to prevent coronary ostial obstruction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If lacerating or severing a portion of leaflets is used to mitigate coronary ostial obstruction, then the risk of blocking coronary ostia is reduced, but high spatial precision and surgical skill are required and aortic insufficiency risk increases

Engineering Contradiction:

Improvecoronary ostial obstruction riskVSAvoidspatial precision requirement

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces mechanical laceration methods with an electrochemical ablation system. An electrode delivers controlled electrical current to the leaflet tissue, causing precise ablation through electrochemical reactions. This substitution eliminates the need for high spatial precision mechanical cutting while achieving the same protective effect against coronary ostial obstruction.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical state and properties of the leaflet tissue through controlled electrical current application. By adjusting electrical parameters (current intensity, duration, frequency), the system achieves precise tissue modification without mechanical contact, thereby reducing operational complexity while maintaining reliability.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If lacerating existing leaflets is performed to prevent coronary obstruction, then coronary ostia protection is improved, but aortic insufficiency risk and vascular occlusion risk increase

Engineering Contradiction:

Improvecoronary ostia protectionVSAvoidaortic insufficiency and vascular occlusion risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrochemical ablation system replaces mechanical laceration, providing controlled tissue modification without the uncontrolled tearing and debris generation associated with mechanical cutting. This reduces the risk of aortic insufficiency and vascular occlusion while maintaining coronary ostia protection.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent converts the potential harm of uncontrolled mechanical laceration into beneficial controlled ablation. By using electrical current to selectively modify leaflet tissue, the system achieves the protective effect against coronary obstruction while minimizing harmful side effects such as debris generation and tissue damage.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If mechanical laceration of calcified leaflets is performed, then coronary ostial obstruction is prevented, but particulate debris is released into the bloodstream causing vascular occlusion or stroke risk

Engineering Contradiction:

Improvecoronary ostial obstruction preventionVSAvoidparticulate debris release

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces mechanical cutting with electrochemical ablation, which vaporizes or dissolves calcified tissue rather than fracturing it. This process eliminates particulate debris generation while effectively preventing coronary ostial obstruction, thereby removing the risk of vascular occlusion and stroke associated with mechanical laceration.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

By controlling electrical current parameters, the system achieves gradual tissue ablation that converts solid calcified material into dissolved or vaporized products rather than particulate debris. This parameter control ensures coronary protection without generating harmful particles.

Inventive Principle:

Principle #35Parameter 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

The method reduces the risk of coronary artery obstruction and aortic insufficiency by precisely modifying leaflets, ensuring smooth blood flow to coronary arteries during prosthetic valve implantation.

Implementation Method 1

providing an electric current to the electrode such that the electric current creates a perforation in a section of material at the predetermined anatomical location

Methodology Applied

Scientific EffectElectric current: Conduction (electrical)

Data Source

PatentUS20250366913A1Perforation assembly with conductive electrode

Publication Date: 2025.12.04 EDWARDS LIFESCIENCES CORP

AI summary

The present disclosure relates to that can be used for forming an opening in a target tissue, such as a host leaflet within which a guest prosthetic valve can be expanded. In an example, a perforation assembly includes a delivery apparatus and an electrode, wherein a distal portion of the electrode, comprising a non-straight shape in a free state thereof, is configured to extend distally from the delivery apparatus.