Truncated Leaflet Prosthetic Valve Design

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Solution Overview

Problem

Bioprosthetic valves prone to calcification and cusp tears, while synthetic leaflet valves suffer from premature failure due to suboptimal design and lack of durable materials, necessitating a more effective synthetic flexible leaflet prosthetic valve solution.

Innovation Solution

A prosthetic valve design featuring a truncated leaflet base and a generally tubular frame with attached film, where the leaflet base is truncated in a specific alpha plane configuration, allowing for a larger alpha angle while maintaining a short valve length, and utilizing a composite material comprising an expanded fluoropolymer membrane with an elastomer for improved durability and flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bioprosthetic valves use biological tissue (bovine pericardium) sewn onto a rigid frame, then excellent hemodynamic and biomechanical performance is achieved in the short term, but the valves are prone to calcification and cusp tears requiring reoperation

Engineering Contradiction:

Improvevalve durabilityVSAvoidcalcification and cusp tears

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from biological tissue to synthetic materials (polymer composites, shape memory alloys), fundamentally altering the chemical and mechanical properties to eliminate calcification and cusp tear failures while maintaining valve function

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials including polymer matrices with reinforcing fibers, and combinations of shape memory alloys with other materials, creating a synthetic leaflet structure that provides both durability and flexibility without the failure modes of biological tissue

Inventive Principle:

Principle #40Composite materials

2Reliability

If synthetic materials (polyurethane) are used to create synthetic leaflet valves, then a more durable flexible leaflet is intended, but the valves suffer premature failure due to suboptimal design and lack of durable material

Engineering Contradiction:

Improvevalve durabilityVSAvoidvalve service life

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent advances synthetic material parameters by using advanced polymer composites and shape memory alloys with superior mechanical properties, fatigue resistance, and biocompatibility compared to earlier polyurethane materials, enabling long-term durability

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent incorporates shape memory alloy components that can dynamically change their mechanical properties in response to temperature or stress changes, allowing the valve to adapt to different physiological conditions while maintaining structural integrity

Inventive Principle:

Principle #15Dynamics

3Length of moving object

If the leaflet base is truncated in alpha plane configuration, then a larger alpha angle is achieved while maintaining short valve length, but the leaflet geometry becomes more complex

Engineering Contradiction:

Improvevalve lengthVSAvoidleaflet geometry

Core Design Contradiction:

Length of moving objectVSShape

Solution Approach 1:

The patent divides the leaflet into distinct geometric zones (truncated base region, alpha plane region, free edge region), allowing each segment to be optimized independently for its specific functional requirements while maintaining overall valve compactness

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 solution provides a durable and flexible prosthetic valve that maintains effective blood flow regulation with reduced risk of calcification and cusp tears, enhancing the longevity and performance of synthetic leaflet valves.

Implementation Method 1

an elastomer present in substantially all of the pores of the expanded fluoropolymer membrane

Methodology Applied

Scientific EffectPore filling: Absorption (physical)

Data Source

PatentUS20240180692A1Truncated leaflet for prosthetic heart valves

Publication Date: 2024.06.06 EDWARDS LIFESCIENCES CORP

AI summary

A prosthetic heart valve can include a frame defining a central longitudinal axis and a plurality of leaflets. Each leaflet can include: a leaflet free edge, a first leaflet side forming a first leaflet side line of attachment along the frame, a second leaflet side forming a second leaflet side line of attachment along the frame, and a leaflet base forming a leaflet base line of attachment along the frame from an end of the first leaflet side line of attachment to an end of the second leaflet side line of attachment. The first leaflet side line of attachment can form a continuous attachment of the first leaflet side to the frame along an entire extent of the first leaflet side. The second leaflet side line of attachment can form a continuous attachment of the second leaflet side to the frame along an entire extent of the second leaflet side.