Electrospun Heart Valve Leaflets With Multi-Layer Mobility

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Solution Overview

Problem

Existing prosthetic heart valves face issues with durability, mobility, and fraying due to their single-layered structure, and bioabsorbable materials used for Endogenous Tissue Restoration (ETR) pose additional durability challenges.

Innovation Solution

A multi-layered heart valve leaflet design, comprising two electrospun layers attached only at the edges or with a middle layer in between, allowing maximum independent movability and incorporating a middle layer for enhanced durability, which can be bioabsorbable or non-bioabsorbable to facilitate ETR.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single-layered structure is used for heart valve leaflets, then the device complexity is reduced, but the leaflet mobility and durability are compromised

Engineering Contradiction:
Improvestructure complexityVSAvoidleaflet durability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The heart valve leaflet is divided into multiple independent layers (typically three layers: two outer layers and one inner layer) that are attached only at the edges or at specific attachment regions. This segmentation allows each layer to move independently, improving leaflet mobility and durability while distributing mechanical stresses across multiple layers, thereby resolving the contradiction between structural simplicity and reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multi-layered leaflet structure features nested layers where inner layers are positioned between outer layers, with selective attachment at edges or specific regions. This nested configuration enables independent movement of each layer while maintaining overall structural integrity, addressing both the need for simplicity and the requirement for enhanced durability through layered redundancy.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Adaptability or versatility

If bioabsorbable materials are used for Endogenous Tissue Restoration (ETR), then tissue integration is improved, but the long-term durability is reduced

Engineering Contradiction:
Improvetissue integrationVSAvoidvalve durability
Core Design Contradiction:
Adaptability or versatilityVSDuration of action of stationary object

Solution Approach 1:

Different layers of the heart valve are made from different materials with distinct properties: outer layers use bioabsorbable materials to facilitate tissue integration and ETR, while inner layers use non-bioabsorbable durable materials to provide long-term structural support. This local differentiation of material properties allows simultaneous achievement of tissue integration and long-term durability.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The heart valve employs a composite structure combining bioabsorbable materials (for ETR and tissue integration) with non-bioabsorbable durable materials (for long-term strength). This composite approach allows the valve to simultaneously achieve biocompatibility, tissue regeneration capability, and sustained mechanical durability over the patient's lifetime.

Inventive Principle:
Principle #40Composite materials

3Strength

If layers are attached across the entire surface, then structural strength is improved, but leaflet mobility is reduced

Engineering Contradiction:
Improvestructural strengthVSAvoidleaflet mobility
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The attachment between layers is segmented and localized to specific regions (edges or attachment zones) rather than spanning the entire leaflet surface. This selective segmentation maintains structural strength at critical load-bearing regions while preserving independent mobility in the unattached areas, allowing the leaflet to move freely during cardiac cycles.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The attachment characteristics vary locally across the leaflet structure: strong attachment at edges and attachment regions provides structural strength, while unattached regions maintain flexibility and independent movement capability. This local differentiation of attachment properties resolves the contradiction between overall strength and local mobility.

Inventive Principle:
Principle #3Local quality

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 multi-layered design significantly improves leaflet mobility and reduces fraying risk while maintaining durability, with the middle layer enhancing overall durability and allowing for tissue integration over time.

Implementation Method 1

electrospinning a polymer solution to form a preform around a mandrel

Methodology Applied
Scientific EffectElectrostatic Deposition: Electrostatic Deposition

Implementation Method 2

The electroprocessed collagen may also be combined with other molecules in order to deliver substances to the site of application or implantation of the electroprocessed collagen. The collagen or collagen/cell suspension is electrodeposited onto a substrate to form tissues and organs.

Methodology Applied
Scientific EffectElectrodeposition: Electrodeposition

Data Source

PatentEP4076286B1Multi-layered electrospun heart valve leaflets
Publication Date: 2026.01.28 XELTIS AG
  • EP4076286B1 patent drawingFigure 1~2
  • EP4076286B1 patent drawingFigure 3
  • EP4076286B1 patent drawingFigure 4

AI summary

Multi-layered engineered designs are provided for heart valve leaflets. The multiple layer designs have significantly improved mobility of the leaflets, without reduced durability, compared to an ordinary single-layer design. In addition, a folded double layer design also showed highly reduced the risk of fraying.