Heart Valve Leaflet Pinwheeling Score Design

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Solution Overview

Problem

Implanting a heart valve prosthesis within a native mitral valve with high ellipticity often results in a lack of coaptation of prosthetic leaflets, leading to undesirable regurgitation due to the elliptical shape of the mitral valve annulus.

Innovation Solution

The heart valve prosthesis is designed with valve leaflets configured to achieve a target pinwheeling score by optimizing the ratio of free edge length to inner diameter, ensuring full contact and minimal overlap between leaflets, and featuring an arcuate base edge, angled commissure edges, and a slightly raised free edge to enhance coaptation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If valve leaflets are designed with conventional dimensions, then the heart valve prosthesis can be delivered through minimally invasive procedures, but the leaflets fail to coapt properly at the center due to ellipticity of the mitral valve annulus, resulting in regurgitation

Engineering Contradiction:
Improvecoaptation qualityVSAvoidcentral regurgitation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies parameter changes by optimizing the free edge length to inner diameter ratio to achieve a target pinwheeling score of 0.94-0.96. This specific parameter optimization ensures that the valve leaflets coapt fully at the center while maintaining minimal overlap, thereby eliminating central regurgitation and improving coaptation quality in elliptical annuli.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs asymmetry by designing the valve leaflets with specific asymmetric geometry including an arcuate base edge and angled commissure edges. This asymmetric configuration allows the leaflets to adapt to the elliptical shape of the mitral valve annulus while maintaining proper coaptation at the center, preventing regurgitation without compromising the low-profile design.

Inventive Principle:
Principle #4Asymmetry

2Reliability

If valve leaflets are designed with increased free edge length to achieve full coaptation, then central regurgitation is minimized, but the risk of valve leaflet abrasion increases

Engineering Contradiction:
Improvecoaptation qualityVSAvoidleaflet durability
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent resolves this contradiction through precise parameter control by limiting the free edge length to achieve a pinwheeling score of 0.94-0.96. This optimized parameter range ensures full coaptation at the center while maintaining minimal overlap between leaflets, thereby preventing abrasion and maintaining durability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies partial action by designing the leaflets with just enough free edge length to achieve proper coaptation (target pinwheeling score 0.94-0.96) without excessive extension that would cause abrasion. The angled commissure edges and arcuate base edge provide the necessary geometry for coaptation while limiting the overall free edge length to prevent wear.

Inventive Principle:
Principle #16Partial or excessive action

3Shape

If valve leaflets are designed with minimal overlap to maintain low profile, then the prosthesis maintains a low profile, but coaptation may be compromised leading to regurgitation

Engineering Contradiction:
Improveprofile heightVSAvoidcoaptation quality
Core Design Contradiction:
ShapeVSReliability

Solution Approach 1:

The patent resolves this contradiction through optimized parameter selection by targeting a pinwheeling score of 0.94-0.96, which corresponds to minimal overlap while ensuring full coaptation at the center. This parameter optimization allows the leaflets to maintain a low profile without compromising coaptation quality, preventing regurgitation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs asymmetry in the leaflet geometry with an arcuate base edge and angled commissure edges that are specifically configured to achieve coaptation with minimal overlap. This asymmetric design allows the leaflets to coapt properly at the center while maintaining a low profile, eliminating the trade-off between profile height and coaptation quality.

Inventive Principle:
Principle #4Asymmetry

Data Source

PatentUS20250009501A1Leaflet design for a heart valve prosthesis
Publication Date: 2025.01.09 MEDTRONIC INC
  • US20250009501A1 patent drawing
  • US20250009501A1 patent drawing
  • US20250009501A1 patent drawing

AI summary

A prosthetic valve component is disclosed for a valve prosthesis. The valve component includes valve leaflets configured to be operably coupled within a frame of the valve prosthesis, wherein each valve leaflet is shaped and sized to achieve a target pinwheeling score PS. The target pinwheeling score correlates to full contact being made between free edges of the valve leaflets, when the valve leaflets are operably coupled within the frame of the valve prosthesis, such that no central opening and little to no overlap occurs between the valve leaflets.