Electrospun Silk Prosthetic Valve Skirts for Paravalvular Sealing

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Solution Overview

Problem

Existing heart valve prostheses face challenges such as paravalvular leakage, difficulty in securing to intra-luminal tissue, and cumbersome manufacturing processes, particularly due to the limitations of PET filaments used in textile construction, which are non-biodegradable and have minimum diameter restrictions.

Innovation Solution

The use of electrospun silk fibers in the construction of implantable prosthetic valves, including annular frames, inner and outer skirts, and leaflet structures, which are radially collapsible and expandable, with optional bicomponent fibers and plasma treatment for enhanced properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If woven or knitted fabric comprising medical-grade polyester (PET) filaments is used for paravalvular leakage sealing, then the textile provides structural support and sealing function, but the manufacturing process is time-consuming and the product has limitations including larger minimum filament diameter (about 10 microns) and non-biodegradability

Engineering Contradiction:

Improvesealing functionVSAvoidmanufacturing process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent changes the fundamental parameters of the textile material by transitioning from woven/knitted PET fabric to electrospun silk fibroin nonwoven fabric. This parameter change enables smaller fiber diameters (sub-micron to micron range), biodegradability, and a more efficient manufacturing process while maintaining or improving sealing functionality through the electrospinning technique that creates densely packed nanofibers

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material strategies by using silk fibroin as the primary biodegradable polymer and potentially combining it with other materials (such as polyurethane or collagen) to create a multifunctional textile that provides both structural support and sealing while being biocompatible and biodegradable, thus resolving the contradiction between reliability and ease of manufacture

Inventive Principle:

Principle #40Composite materials

2Ease of manufacture

If PET filaments with minimum diameter of about 10 microns are used, then the textile can be manufactured, but the surface area, smoothness, and tensile properties are limited

Engineering Contradiction:

Improvetextile productionVSAvoidtensile properties

Core Design Contradiction:

Ease of manufactureVSStrength

Solution Approach 1:

The patent applies parameter changes by reducing the fiber diameter from microns (PET) to sub-micron and micron range (silk fibroin nanofibers) through electrospinning. This parameter change increases the surface area-to-volume ratio and allows for higher tensile strength and smoother surfaces while maintaining manufacturability through the electrospinning process

Inventive Principle:

Principle #35Parameter changes

3Productivity

If conventional textiles are used for prosthetic valve construction, then the manufacturing process is cumbersome and expansive, but the patent seeks to simplify manufacturing while maintaining device functionality

Engineering Contradiction:

Improvemanufacturing efficiencyVSAvoidmanufacturing process

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical weaving or knitting processes with electrospinning, an electrostatic field-based process that directly deposits fibers into the desired shape. This substitution eliminates complex mechanical looms and knitting machines, reducing manufacturing complexity and expense while improving productivity through a more direct fabrication approach

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

The electrospun silk fibers provide improved mechanical properties, biodegradability, and ease of manufacturing, reducing paravalvular leakage and securing issues while allowing for minimally invasive procedures.

Implementation Method 1

electrospun silk fibroin nonwoven meshes... The electrospinning process uses electrostatic forces to draw and deposit fibers

Methodology Applied

Scientific EffectElectrostatic forces: Electrostatics

Implementation Method 2

with optional bicomponent fibers and plasma treatment for enhanced properties

Methodology Applied

Scientific EffectPlasma treatment: Plasma

Data Source

PatentEP4120961B1Silk-based electrospun materials for implant systems and devices

Publication Date: 2025.10.29 EDWARDS LIFESCIENCES CORP

Figure 1~2
Figure 3A~3B
Figure 3C~4(f)

AI summary

An implantable prosthetic valve may include an annular frame having an inner surface and an outer surface and the frame has an inflow end and an outflow end and a central longitudinal axis extending from the inflow end to the outflow end. A leaflet structure may be positioned within the frame. An inner skirt may be positioned along the inner surface of the frame. An outer skirt may be positioned around the outer surface of the frame. Various portions of the leaflet structure, the inner skirt, or outer skirt may incorporate a material inclusive of electrospun silk.