Prosthetic Heart Valve Commissure Coupling to Limit Leaflet Wear

Solution Overview

Problem

Existing prosthetic heart valves face challenges in maintaining optimal leaflet articulation and minimizing pressure gradients across a wide range of valve diameters, leading to wear and damage due to inconsistent offset distances between leaflet articulation axes and the frame.

Innovation Solution

The prosthetic heart valves feature adjustable offset elements at the commissures, allowing for variable offset distances between leaflet articulation axes relative to the frame, which can shift between neutral and outward positions to accommodate different diameters, reducing wear and enhancing effective outflow area while maintaining low pressure gradients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed offset distance is used between leaflet articulation axes and the frame, then the valve structure is simple, but the valve cannot maintain optimal leaflet articulation across a wide range of valve diameters

Engineering Contradiction:

Improveadaptability across valve diametersVSAvoidoffset element adjustability mechanism

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The offset elements are designed to be movable relative to the frame between a neutral position and an outward shifted position, allowing the offset distance to dynamically adapt to different valve diameters. This dynamic adjustment enables optimal leaflet articulation across a wide range of valve sizes without requiring multiple fixed designs.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The invention changes the parameter of offset distance by allowing offset elements to shift between positions. When the valve is expanded to different diameters, the offset elements can be positioned to provide the appropriate offset distance, maintaining optimal leaflet articulation and minimizing pressure gradients across varying valve sizes.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If the offset elements are fixed in position, then the manufacturing precision is high, but the valve cannot accommodate varying diameters and leads to increased wear

Engineering Contradiction:

Improvereduction of leaflet wearVSAvoidmoveable offset element structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The offset elements are designed to be movable relative to the frame between a neutral position and an outward shifted position, allowing the offset distance to dynamically adapt to different valve diameters. This dynamic adjustment enables optimal leaflet articulation across a wide range of valve sizes without requiring multiple fixed designs.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The offset elements are pre-configured with multiple positions (neutral and outward shifted) that can be selected before implantation based on the required valve diameter. This preliminary configuration ensures that the appropriate offset distance is established in advance, preventing leaflet wear during operation.

Inventive Principle:

Principle #10Preliminary action

3Productivity

If a single fixed diameter design is used, then the device complexity is low, but the effective outflow area cannot be optimized across different diameters

Engineering Contradiction:

Improveeffective outflow areaVSAvoidadjustable offset mechanism

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The invention changes the parameter of offset distance by allowing offset elements to shift between positions. When the valve is expanded to different diameters, the offset elements can be positioned to provide the appropriate offset distance, maintaining optimal leaflet articulation and minimizing pressure gradients across varying valve sizes.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The valve design incorporates universal offset elements that can function across multiple valve diameters. By positioning the offset elements in different states (neutral or outward shifted), the same valve structure can optimize effective outflow area for various diameter requirements, eliminating the need for multiple specialized valve designs.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

This design enables the prosthetic heart valves to maintain effective outflow area and minimize pressure gradients across varying diameters, reducing leaflet wear and improving functional performance.

Implementation Method 1

a radially compressible and expandable annular frame

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS20250288415A1Prosthetic heart valves with commissure coupling elements

Publication Date: 2025.09.18 EDWARDS LIFESCIENCES CORP

AI summary

A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets and a plurality of offset elements. Each leaflet includes a leaflet free edge that is offset in an axial direction from the commissures by upper material portions that are unattached to the frame. Commissures are formed by primary tabs on the side edges of adjacent leaflets attached to secondary tabs on opposing ends of the offset elements. A bridge portion of the offset elements extends over an end portion of the leaflet free edges of the adjacent leaflets and is moveable between a neutral position and a radially outward shifted position. An articulation axis between the adjacent leaflets is offset greater distance from the frame when the bridge portion is in the neutral position relative to when the bridge portion is in the radially outward shifted position.