Temporary Valve Inversion for Coronary Perfusion

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Solution Overview

Problem

Current methods for percutaneous valve replacement, such as TAVI and TAVR, face challenges in maintaining adequate coronary perfusion during the removal or replacement of damaged heart valves, as existing temporary valves cannot be positioned effectively inside the left ventricle to prevent aortic regurgitation and allow for the implantation of a new valve without interfering with the procedure.

Innovation Solution

A device with a temporary valve positioned just below the damaged heart valve inside the left ventricle, acting as both a functional valve and a guide for the implantation of a replacement valve, which is minimally invasive and easily removable, utilizing a support body with a flexible tip and a self-expandable frame to maintain position and facilitate the removal of damaged leaflets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the temporary valve is positioned in the ascending aorta above the aortic valve, then the valve can be easily accessed, but it does not allow diastole blood flow to perfuse the coronary arteries and may interfere with TAV implantation

Engineering Contradiction:
Improveaccessibility of temporary valveVSAvoidcoronary perfusion and TAV implantation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The temporary valve is inverted and positioned in the left ventricle below the aortic valve instead of above it. This inversion allows the valve to function correctly while enabling coronary artery perfusion during diastole and preventing interference with TAV implantation in the ascending aorta

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The temporary valve is repositioned from the ascending aorta to the left ventricle, changing the spatial dimension and location. This dimensional change allows simultaneous achievement of coronary perfusion, non-interference with TAV, and temporary valve functionality

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Speed

If the delivery catheter is passed through the damaged aortic valve, then the catheter can reach the ventricle, but the delivery catheter itself prevents the implantation of the new TAV valve

Engineering Contradiction:
Improvecatheter delivery speedVSAvoidTAV implantation capability
Core Design Contradiction:
SpeedVSAdaptability or versatility

Solution Approach 1:

A guide body is introduced as an intermediary device that remains in the left ventricle after temporary valve deployment. This guide body serves as a rail for delivering the TAV catheter, allowing the catheter to reach the ventricle without passing through the damaged aortic valve, thus enabling both fast delivery and successful TAV implantation

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If the damaged valve leaflets are removed quickly, then the procedure time is reduced, but the patient experiences severe aortic regurgitation and hemodynamic instability

Engineering Contradiction:
Improveprocedure speedVSAvoidhemodynamic stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The temporary valve is deployed in the left ventricle before the damaged leaflets are removed. This preliminary action establishes hemodynamic stability and enables coronary perfusion before the critical removal step, allowing rapid leaflet removal without compromising patient safety

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The temporary valve acts as a protective measure deployed beforehand to cushion against the hemodynamic instability that would result from rapid leaflet removal. It ensures continuous coronary perfusion and prevents severe aortic regurgitation during the critical transition period

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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

Ensures stable coronary perfusion and allows for the successful implantation of a new valve without interfering with the replacement process, providing a safe and effective solution for valve replacement procedures.

Implementation Method 1

a self-expandable frame to maintain position

Methodology Applied
Scientific EffectSelf-expansion: Elasticity

Data Source

PatentEP4183370A1Device with a temporary valve for percutaneous delivery in a natural or artificial aortic valve
Publication Date: 2023.05.24 LEAFMATE SRL
  • EP4183370A1 patent drawingFigure 1~2
  • EP4183370A1 patent drawingFigure 3~4
  • EP4183370A1 patent drawingFigure 5~6

AI summary

The device with a temporary valve (1) according to the present invention comprises: - a support body (3) with a flexible tip (31); - a temporary umbrella valve (2), with a distal apex (23), a frame (21) and with a membrane (22); - a sheath (4) sliding to keep the temporary valve (2) in a collapsed configuration. The subject device (1) is characterized in that the frame (21) comprises a proximal edge (212) from which main uprights (211) start, which uprights are connected to each other at the apex (23). The frame (21) allows the passage of the temporary valve (2) from the operating configuration to a collapsed extraction configuration in which the umbrella valve is turned inside out to be easily retrieved without interfering with a possible new aortic valve (Transcatheter Aortic Valve - TAV) that has just been implanted.