Coated Fibrous Prosthetic Valve Leaflets

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Solution Overview

Problem

Prosthetic heart valve leaflets made from synthetic materials face degradation due to their small diameter, which increases their surface area to mass ratio, leading to potential failure over time in the in vivo environment.

Innovation Solution

The use of fibrous valve leaflets with polymeric fibers coated with a metal oxide layer, such as aluminum oxide, to prevent degradation, where the fibers are deposited using techniques like electrospinning or weaving and coated using gas phase deposition methods like atomic layer deposition, enhancing their strength and durability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If synthetic materials are used for valve leaflets, then manufacturing precision and ease of manufacture are improved, but reliability and duration of action deteriorate due to degradation from high surface area to mass ratio

Engineering Contradiction:
Improveease of manufactureVSAvoidreliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies composite materials by combining synthetic polymeric fibers with a metal oxide coating layer. The fibrous matrix provides ease of manufacture and structural integrity, while the metal oxide coating layer protects against degradation from the in vivo environment. This composite structure resolves the contradiction by maintaining the manufacturing advantages of synthetic materials while adding the durability and reliability of metal oxide protection.

Inventive Principle:
Principle #40Composite materials

2Area of moving object

If fiber diameter is reduced to improve hemodynamic performance, then area of moving object and hemodynamic performance are improved, but reliability deteriorates due to increased surface area to mass ratio leading to degradation

Engineering Contradiction:
Improvearea of moving objectVSAvoidreliability
Core Design Contradiction:
Area of moving objectVSReliability

Solution Approach 1:

The patent uses composite materials with a metal oxide coating on the polymeric fibers to protect the high-surface-area fiber structure from degradation in the in vivo environment, resolving the contradiction between improved hemodynamic performance and reduced reliability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the physical and chemical parameters of the fiber surface by applying a metal oxide coating. This coating alters the surface properties to resist degradation from bodily fluids and enzymes, allowing the fibers to maintain their small diameter and high surface area without suffering from the associated reliability issues.

Inventive Principle:
Principle #35Parameter changes

3Area of moving object

If fiber diameter is reduced to improve hemodynamic performance, then area of moving object and hemodynamic performance are improved, but strength and duration of action worsen due to increased susceptibility to degradation

Engineering Contradiction:
Improvearea of moving objectVSAvoidstrength
Core Design Contradiction:
Area of moving objectVSStrength

Solution Approach 1:

The patent applies composite materials by coating polymeric fibers with metal oxide to create a protective barrier that prevents degradation. This resolves the contradiction by allowing the use of small-diameter fibers for improved hemodynamics while the metal oxide coating maintains the structural strength and durability needed for long-term performance.

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

The coated fibrous matrix exhibits improved strength and resistance to degradation, maintaining performance over time and approximating the hemodynamic performance of healthy natural valves.

Implementation Method 1

A coating can surround the polymeric fibers within the fibrous matrix. The coating can have a thickness of about 3 to about 30 nanometers. The coating can be formed of a material selected from the group consisting of a metal oxide, a nitride, a carbide, a sulfide, or fluoride. In some examples, the coating surrounding the polymeric fibers prevents the penetration of water there through.

Methodology Applied
Scientific EffectPhysical barrier (coating): Coatings

Implementation Method 2

The leaflets can include a fibrous matrix, the fibrous matrix including polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. A coating can surround the polymeric fibers within the fibrous matrix.

Methodology Applied
Scientific EffectGas phase deposition: Chemical Vapour Deposition

Data Source

PatentUS11559394B2Prosthetic valves, valve leaflets and related methods
Publication Date: 2023.01.24 BOSTON SCIENTIFIC SCIMED INC
  • US11559394B2 patent drawing
  • US11559394B2 patent drawing
  • US11559394B2 patent drawing

AI summary

Examples herein include prosthetic valves, valve leaflets and related methods. In an example, a prosthetic valve is included having a plurality of leaflets. The leaflets can each have a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion. The leaflets can include a fibrous matrix including polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. A coating can surround the polymeric fibers within the fibrous matrix. The coating can have a thickness of about 3 to about 30 nanometers. The coating can be formed of a material selected from the group consisting of a metal oxide, a nitride, a carbide, a sulfide, or fluoride. In an example, a method of making a valve is included. Other examples are also included herein.