Leaflet-Engaging Support Frame for Valve Annulus Stabilization

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Solution Overview

Problem

Existing prosthetic heart valves face challenges in treating conditions like aortic and mitral insufficiency due to lack of support from non-calcified leaflets, varying annulus diameters, and complications from self-expanding valves that exacerbate conditions and require larger sizes, complicating delivery.

Innovation Solution

A percutaneous ring-shaped support structure with adjustable leaflet-engaging mechanisms that reduce the aortic valve annulus diameter by clipping onto native leaflets, providing secure anchoring and controlled delivery of prosthetic valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If balloon-expandable valves are used, then the valve can be anchored to calcified tissue, but the leaflets are too soft to provide sufficient support when non-calcified

Engineering Contradiction:

Improveanchoring reliabilityVSAvoidleaflet support strength

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The support frame is deployed before the prosthetic valve to prepare the implantation site. The frame engages with the native valve structure in advance, creating a stable foundation that compensates for insufficient leaflet support, allowing subsequent valve anchoring to proceed reliably

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The support frame acts as an intermediary structure between the delivery system and the native valve. It provides mechanical support and anchoring points that the soft leaflets cannot provide alone, mediating the force transmission and stabilizing the implantation site

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If self-expanding prosthetic valves are used, then they can replace defective valves, but the outward force causes the valve annulus to dilate further

Engineering Contradiction:

Improvevalve replacement capabilityVSAvoidannulus dilation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The support frame applies a counteracting force to the outward expansion tendency of self-expanding valves. By engaging with the native valve structure first, it resists the dilating force and maintains annulus diameter within acceptable limits during valve implantation

Inventive Principle:

Principle #9Preliminary anti-action

Solution Approach 2:

The support frame provides a counterbalancing structural support that offsets the outward biasing force of self-expanding prosthetic valves. This counterweight effect prevents excessive annulus dilation while allowing the valve to function

Inventive Principle:

Principle #8Anti-weight (Counterweight)

3Ease of operation

If self-expanding valves are used, then valve replacement can be achieved, but the valve is ejected very quickly from the delivery sheath

Engineering Contradiction:

Improvevalve implantationVSAvoidvalve ejection speed

Core Design Contradiction:

Ease of operationVSSpeed

Solution Approach 1:

The support frame is deployed and anchored to the native valve structure before the prosthetic valve is released. This preliminary anchoring creates mechanical constraints that slow down and control the valve ejection process, preventing rapid uncontrolled deployment

Inventive Principle:

Principle #10Preliminary action

4Reliability

If larger prosthetic valve sizes are used to treat insufficiency, then valve function can be restored, but delivery becomes much more difficult

Engineering Contradiction:

Improvevalve function restorationVSAvoiddelivery procedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The implantation system is divided into separate components: a deployable support frame and a prosthetic valve. The support frame is delivered and positioned first, creating a stable platform that simplifies subsequent valve deployment, breaking down the complex task of delivering large valves into manageable steps

Inventive Principle:

Principle #1Segmentation

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 valve annulus diameter, ensuring secure implantation of prosthetic valves, preventing further dilation and simplifying delivery, thereby improving valve function and reducing complications.

Implementation Method 1

the support frame is radially expandable from a compressed state to a deployed state

Methodology Applied

Scientific EffectRadial expansion:

Implementation Method 2

engaging the support frame with the native valve structure. The support frame includes a plurality of leaflet-engaging mechanisms

Methodology Applied

Scientific EffectMechanical engagement: Mechanical Force

Data Source

PatentUS12419746B2Valvular insufficiency repair device and method

Publication Date: 2025.09.23 EDWARDS LIFESCIENCES CORP

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 a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.