Electrospun Fiber Reinforced Heart Valve Leaflets

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Solution Overview

Problem

Current prosthetic heart valves made from single-layered materials like pericardium have limited long-term durability and fail to mimic the mechanical properties of natural heart valves, leading to leaflet rupture during durability tests.

Innovation Solution

The method involves electrospinning aligned and non-aligned bioabsorbable polymer fibers simultaneously onto a mandrel to create a heart valve leaflet with a circumferentially aligned band, enhancing durability and flexibility while allowing for endogenous tissue restoration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If single layered pericardium is used to make prosthetic heart valves, then the manufacturing process is simple, but the long term durability is limited and leaflet rupture occurs during durability tests

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidlong term durability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies composite materials by combining multiple layers of electrospun fibers with different orientations (aligned and non-aligned) and potentially different material compositions. This multi-layer composite structure provides enhanced mechanical properties and durability compared to single-layered pericardium, while still being manufacturable through the electrospinning process.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If artificial scaffolds are designed to be thin and flexible for proper opening and closing, then the mobility is maintained, but the durability is reduced and leaflet rupture occurs

Engineering Contradiction:
ImprovemobilityVSAvoiddurability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies local quality by creating regions with different fiber orientations and densities at specific locations within the heart valve leaflet. The electrospun scaffold incorporates both aligned and non-aligned fiber regions, providing localized mechanical properties that balance flexibility for proper valve operation with sufficient strength to prevent rupture under stress.

Inventive Principle:
Principle #3Local quality

3Strength

If natural heart valve tri-layer structure is mimicked with aligned reinforcement, then the mechanical properties are improved, but the manufacturing complexity increases

Engineering Contradiction:
Improvemechanical propertiesVSAvoidstructural complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent replaces the complex mechanical assembly of layered natural heart valve tissue with an electrospun fibrous scaffold that inherently provides the necessary mechanical properties through controlled fiber orientation and distribution. The electrospinning process creates a biomimetic structure that mimics the natural extracellular matrix architecture without requiring complex multi-step assembly procedures.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 approach results in a heart valve with improved mechanical properties, increased durability, and enhanced integration and adhesion, allowing for effective replacement with newly formed tissue over time.

Implementation Method 1

Aligned fibers are electrospun onto a mandrel using a first source. Non-aligned fibers are electrospun onto the mandrel using a second source.

Methodology Applied
Scientific EffectElectrospinning: Electrostatic Deposition

Data Source

PatentEP4259040B1Reinforced heart valve leaflets
Publication Date: 2025.02.19 XELTIS AG
  • EP4259040B1 patent drawingFigure 1
  • EP4259040B1 patent drawingFigure 2
  • EP4259040B1 patent drawingFigure 3

AI summary

A heart valve with reinforced leaflets is provided. The free edge of the leaflet and/or the leaflet belly area of the leaflet has a circumferentially aligned band of aligned electrospun fibers with non-aligned fibers. The aligned and/or the non-aligned fibers are bioabsorbable polymer fibers, and are capable of being replaced over time with newly formed tissue. A method is provided to make these heart valve leaflets using two sources of electrospinning which electrospun simultaneously to either form distinct layers or intermixed layers of aligned and non-aligned fibers.