Electrospun Fiber Reinforced Heart Valve Leaflets

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Solution Overview

Problem

Prosthetic heart valves face challenges with long-term chemical stability and mechanical durability due to calcification and material-related failures, such as tearing, which affect their functionality over time.

Innovation Solution

The development of prosthetic heart valves with leaflets made from a fibrous composite material composed of electrospun fibers embedded in a polyisobutylene urethane copolymer matrix, which includes a combination of polyisobutylene urethane copolymers with varying hard and soft segment percentages, along with a hydrogel coating for enhanced properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional prosthetic heart valve materials are used, then the valve can be manufactured and implanted, but the valve leaflets accumulate calcium deposits over time and experience material failures such as tearing

Engineering Contradiction:
Improvelong-term chemical stability and mechanical durabilityVSAvoidservice life of valve leaflets
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent employs a composite material system consisting of a polymer matrix (e.g., polyurethane, polyester, or silicone) reinforced with electrospun fibers (e.g., polymeric, ceramic, or metallic fibers). This composite structure provides enhanced mechanical strength, flexibility, and resistance to calcification compared to conventional single-material valves, directly addressing the reliability and durability issues

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of the valve leaflet materials by controlling the electrospinning process parameters (voltage, flow rate, needle-gauge distance) to produce fibers with specific diameters, orientations, and densities. These parameter changes enable tailoring of the material properties to optimize both mechanical performance and resistance to calcification over time

Inventive Principle:
Principle #35Parameter changes

2Strength

If the valve leaflets are made more durable to resist tearing, then mechanical strength is improved, but the material may become less flexible to withstand pulsating heart stresses

Engineering Contradiction:
Improvemechanical strength and resistance to tearingVSAvoidflexibility to withstand pulsating stresses
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The patent implements local quality by creating regions with different fiber concentrations, orientations, and material compositions within the valve leaflet structure. For example, areas experiencing higher stress may have denser fiber reinforcement, while other regions maintain higher flexibility. This spatial variation in material properties allows the valve to simultaneously achieve both strength and adaptability

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The combination of polymer matrix with electrospun fibers creates a composite material that inherently balances strength and flexibility. The fibers provide tensile strength and tear resistance, while the polymer matrix maintains elasticity and flexibility, allowing the leaflet to withstand both mechanical stresses and pulsating heart conditions

Inventive Principle:
Principle #40Composite materials

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 solution provides improved mechanical strength, resistance to calcification, and prolonged functionality by tailoring the physical and mechanical properties of the valve leaflets to withstand the stresses and strains of a pulsating heart, reducing the risk of material failures like tearing.

Implementation Method 1

a fibrous composite material composed of electrospun fibers embedded in a polyisobutylene urethane copolymer matrix

Methodology Applied
Scientific EffectElectrostatic forces: Electrostatics

Implementation Method 2

electrospun fibers embedded in a polyisobutylene urethane copolymer matrix

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 3

along with a hydrogel coating for enhanced properties

Methodology Applied
Scientific EffectHydrogel coating: Hydrogel

Data Source

PatentEP3280358B1Prosthetic heart valves having fiber reinforced leaflets
Publication Date: 2022.11.16 BOSTON SCIENTIFIC SCIMED INC
  • EP3280358B1 patent drawingFigure 1
  • EP3280358B1 patent drawingFigure 2
  • EP3280358B1 patent drawingFigure 3A~3B

AI summary

A prosthetic heart valve leaflet includes a plurality of electrospun fibers at least partially embedded in a polymer matrix. The plurality of fibers includes a first polyisobutylene urethane copolymer having a first predetermined weight average percentage of hard segment portions and the polymer matrix includes a second polyisobutylene urethane copolymer having a second predetermined weight average percentage of the hard segment portions, wherein the first predetermined weight average percentage of the hard segment portions is greater than the second predetermined weight average percentage of the hard segment portions.