Polymeric Transcatheter Heart Valves With Stress-Reduced Leaflets

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Solution Overview

Problem

Transcatheter implantation of bioprosthetic heart valves faces challenges due to the finite life span of biological tissue leaflets, exacerbated by catheter-based implantation, which causes creases susceptible to calcification, and existing manufacturing methods introduce stress concentrations leading to premature degradation.

Innovation Solution

Prosthetic heart valves with artificial polymeric leaflets and a contractable stent structure are manufactured using dip casting, allowing for reduced radial dimensions for delivery and expansion to functional size, eliminating the need for suturing and reducing stress on the leaflets, with manufacturing methods that minimize stress concentrations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If bioprosthetic valves are implanted via catheter, then minimally invasive implantation is achieved, but the tissue leaflets are creased and susceptible to calcification

Engineering Contradiction:

Improveimplantation methodVSAvoidleaflet durability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent changes the material parameter from biological tissue to synthetic polymer, which eliminates the creasing and calcification problems associated with catheter-based implantation of bioprosthetic valves while maintaining the minimally invasive delivery approach

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs a self-expanding stent mechanism that is deployed and then discarded, allowing the valve to expand to its functional configuration after delivery through the catheter without requiring complex retrieval mechanisms

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Volume of moving object

If valve is reduced to smaller cross-sectional size for catheter implantation, then minimally invasive delivery is enabled, but tissue leaflets are creased and calcification rate increases

Engineering Contradiction:

Improvevalve sizeVSAvoidleaflet integrity

Core Design Contradiction:

Volume of moving objectVSReliability

Solution Approach 1:

The patent changes the material properties from biological tissue to synthetic polymer, which can withstand compression and expansion cycles without creasing or calcifying, enabling safe size reduction for catheter delivery

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs a self-expanding stent mechanism that dynamically transitions from a compressed delivery state to an expanded functional state, with the polymer leaflets designed to accommodate this dynamic transformation without structural degradation

Inventive Principle:

Principle #15Dynamics

3Productivity

If existing manufacturing methods are used, then valve production is achieved, but stress concentrations cause premature degradation

Engineering Contradiction:

Improvemanufacturing capabilityVSAvoidvalve lifespan

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent merges the stent and leaflet manufacturing into a single integrated process where the polymer leaflets are formed as an integral part of the stent structure, eliminating separate assembly steps that could introduce stress concentrations

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent changes the manufacturing approach from traditional assembly methods to a unified molding process that creates smooth transitions and eliminates stress concentration points inherent in multi-component assembled valves

Inventive Principle:

Principle #35Parameter changes

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 prosthetic valves offer a longer lifespan and improved manufacturability, reducing stress on polymer leaflets and preventing long-term degradation, enabling non-invasive catheter-based implantation with enhanced durability and ease of use.

Implementation Method 1

a dip casting or dipping process that involves immersing some or all of an element of the prosthetic valve (or used in formation of the prosthetic heart valve) into a wet polymer to form a coating of polymer thereon

Methodology Applied

Scientific EffectDip casting: Deposition (physical)

Data Source

PatentUS20260000506A1Systems, devices, and methods relating to the manufacture of intravascularly implantable prosthetic valves

Publication Date: 2026.01.01 FOLDAX INC

AI summary

Improved prosthetic heart valves, their methods of manufacture, and systems and devices for manufacturing the valves are described. The prosthetic heart valves can be configured for transcatheter implantation. The prosthetic heart valves can have artificial leaflets. The prosthetic heart valves can be manufactured in numerous ways, such as by polymeric dipping processes.