Leaflet-Clipping Annular Support for Aortic Insufficiency Repair

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Solution Overview

Problem

Existing prosthetic heart valves face challenges in treating conditions like aortic insufficiency and mitral insufficiency due to issues with balloon-expandable valves lacking sufficient support for soft leaflets and self-expanding valves causing further annulus dilation, along with delivery complications from frame attachment requirements.

Innovation Solution

A percutaneous, minimally invasive annular support structure that clips onto native leaflets at the commissures to reduce the aortic valve annulus diameter, using a radially expandable and collapsible frame with leaflet-engaging mechanisms for precise prosthetic valve delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If balloon-expandable valves are used to treat aortic insufficiency, then the valve can be anchored in the valve annulus, but the soft leaflets cannot provide sufficient support for the prosthetic valve

Engineering Contradiction:

Improveanchoring capabilityVSAvoidleaflet support structure

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

A self-expanding stent is introduced as an intermediary structure between the soft native leaflets and the balloon-expandable prosthetic valve. The stent provides the necessary structural support and anchoring capability, allowing the prosthetic valve to be securely mounted while the soft leaflets can still function as intended.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If self-expanding prosthetic valves are used, then the valve can be implanted without requiring hardened leaflets, but the continuous outward pressure causes the valve annulus to dilate further

Engineering Contradiction:

Improveimplantation simplicityVSAvoidannulus dilation

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The design transitions from a self-expanding valve that continuously exerts outward pressure to a balloon-expandable valve that achieves its expanded state through controlled balloon inflation. This parameter change in the expansion mechanism eliminates the continuous outward pressure on the annulus while maintaining proper valve deployment.

Inventive Principle:

Principle #35Parameter changes

3Ease of manufacture

If self-expanding prosthetic valves are used, then the valve can be implanted without hardened leaflets, but the outward biasing force causes the valve to be ejected quickly from the delivery sheath

Engineering Contradiction:

Improveimplantation simplicityVSAvoiddelivery control

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The self-expanding mechanical system is replaced with a balloon-expandable system. The balloon inflation mechanism provides controlled expansion forces that can be precisely regulated during delivery, preventing premature ejection from the delivery sheath while ensuring proper deployment at the target site.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Area of stationary object

If a larger prosthetic valve size is used to treat aortic or mitral insufficiency, then the valve can address the dilated annulus, but the delivery procedure becomes much more difficult

Engineering Contradiction:

Improvevalve sizeVSAvoiddelivery procedure

Core Design Contradiction:

Area of stationary objectVSEase of operation

Solution Approach 1:

The large-diameter prosthetic valve is nested within a collapsible delivery catheter in a compressed state, allowing it to pass through small access vessels. Upon balloon inflation at the target site, the valve expands to its full functional size, enabling treatment of dilated annuli while maintaining ease of delivery through minimally invasive access.

Inventive Principle:

Principle #7Nested doll (Nesting)

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 support structure effectively reduces the aortic valve annulus diameter, providing stable anchoring for prosthetic valves and improving valve function by minimizing dilation and simplifying delivery, suitable for aortic and mitral insufficiency treatments.

Implementation Method 1

a radially expandable and collapsible frame

Methodology Applied

Scientific EffectRadial expansion and collapse: Elasticity

Data Source

PatentEP3735938B1Aortic insufficiency repair device

Publication Date: 2026.03.04 EDWARDS LIFESCIENCES CORP

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AI summary

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises an annular main body formed by a plurality of angled struts, the main body including a plurality of peaks formed by the intersection of respective adjacent struts. The support frame further comprises one or more leaflet-engaging mechanisms configured to engage leaflets of the heart valve. The support frame can be radially expandable and collapsible.