Prosthetic Heart Valve Leaflets Using Composite Materials

Solution Overview

Problem

Prosthetic heart valves made from animal tissue face issues such as calcification, erosion, and limited lifespan, necessitating the development of alternative materials that are resistant to calcification and can maintain functionality over an extended period.

Innovation Solution

The use of composite materials for leaflets, including a metal substrate with a polymer coating, a woven or knitted metal mesh, or natural tissue subjected to plastination preservation, to create prosthetic heart valves that are resistant to calcification and suitable for both surgical and transcatheter implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If animal tissue is used for prosthetic heart valve leaflets, then the valve can be manufactured with available biological materials, but the leaflets will calcify and erode over time, limiting their lifespan

Engineering Contradiction:

Improveavailability of biological materialsVSAvoidresistance to calcification

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent applies composite materials by combining a metal substrate (such as stainless steel or cobalt-chromium alloy) with a polymer coating (such as polyurethane or PTFE) to create a leaflet material that integrates the structural strength of metal with the biocompatibility and non-calcifying properties of polymer, thereby resolving the contradiction between manufacturability and resistance to calcification

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent applies parameter changes by treating natural tissue through chemical fixation processes (such as glutaraldehyde cross-linking) or physical treatments (such as freeze-drying or irradiation) to modify the tissue's chemical and physical parameters, making it more resistant to calcification and degradation while preserving its functional properties

Inventive Principle:

Principle #35Parameter changes

2Ease of manufacture

If animal tissue is used for prosthetic heart valve leaflets, then the valve can be manufactured with available biological materials, but the leaflets will eventually erode or tear, creating a need for further surgical intervention

Engineering Contradiction:

Improveavailability of biological materialsVSAvoidfunctional lifespan of leaflet

Core Design Contradiction:

Ease of manufactureVSDuration of action of stationary object

Solution Approach 1:

The patent applies composite materials by combining a metal substrate (such as stainless steel or cobalt-chromium alloy) with a polymer coating (such as polyurethane or PTFE) to create a leaflet material that integrates the structural strength of metal with the biocompatibility and non-calcifying properties of polymer, thereby resolving the contradiction between manufacturability and resistance to calcification

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent applies parameter changes by treating natural tissue through chemical fixation processes (such as glutaraldehyde cross-linking) or physical treatments (such as freeze-drying or irradiation) to modify the tissue's chemical and physical parameters, making it more resistant to calcification and degradation while preserving its functional properties

Inventive Principle:

Principle #35Parameter changes

3Strength

If thicker leaflet material is used, then the valve structure will be stronger and more durable, but the valve cannot be collapsed to a smaller size for percutaneous delivery

Engineering Contradiction:

Improvestructural strength of leafletVSAvoidcollapsed size of valve

Core Design Contradiction:

StrengthVSVolume of moving object

Solution Approach 1:

The patent applies composite materials by combining a metal substrate (such as stainless steel or cobalt-chromium alloy) with a polymer coating (such as polyurethane or PTFE) to create a leaflet material that integrates the structural strength of metal with the biocompatibility and non-calcifying properties of polymer, thereby resolving the contradiction between manufacturability and resistance to calcification

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent applies flexible shells and thin films by using thin polymer coatings (ranging from 1 to 100 micrometers in thickness) that provide sufficient structural integrity and strength while maintaining extreme thinness, enabling the valve to be collapsed to a small size for percutaneous delivery through catheters

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS20240415637A1Prosthetic Leaflets for Valve Replacement

Publication Date: 2024.12.19 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.