Biodegradable Composite Heart Valve for Durable Thrombus Resistance

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Solution Overview

Problem

Current valve replacement technologies, including metallic and bioprosthetic valves, face limitations such as the need for anticoagulation therapy with metallic valves and structural deterioration within five years with bioprosthetic valves, necessitating a solution for non-thrombogenic long-term durability and adaptability to somatic growth.

Innovation Solution

A prosthetic heart valve device comprising a biocompatible and biodegradable metal frame with openings and a biodegradable polymeric heart valve, featuring a balloon-expandable design for minimally invasive delivery, which includes a biodegradable magnesium alloy frame and polymeric heart valve with antithrombogenic coatings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If metallic valves are used, then durability is improved, but the need for anticoagulation therapy increases

Engineering Contradiction:

ImprovedurabilityVSAvoidanticoagulation therapy

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent employs a composite structure combining a metallic frame (providing structural durability and mechanical strength) with a polymeric valve component (providing thrombus resistance and biological compatibility). This composite approach allows the metallic frame to ensure long-term structural integrity while the polymeric material provides non-thrombogenic properties, thereby resolving the contradiction between durability and anticoagulation requirements

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The polymeric material acts as an intermediary layer between the metallic frame and the bloodstream. This intermediate polymeric component interfaces with blood flow and prevents thrombus formation, while the metallic frame provides the underlying structural support. This intermediary approach allows the system to achieve both durability and thrombus resistance without requiring anticoagulation therapy

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If bioprosthetic valves are used, then anticoagulation therapy is avoided, but structural deterioration occurs within five years

Engineering Contradiction:

Improveanticoagulation therapyVSAvoidstructural durability

Core Design Contradiction:

Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The invention uses a composite construction where a metallic frame provides the structural backbone for long-term durability, while a polymeric valve component provides thrombus resistance. This composite structure avoids the structural deterioration problem of pure bioprosthetic valves by incorporating the mechanical strength of metals, while maintaining the non-thrombogenic properties of polymers

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent modifies the material parameters by selecting specific polymeric materials with optimized mechanical properties and degradation characteristics. The polymeric component is engineered to maintain structural integrity over the long term while providing thrombus resistance, thereby changing the performance parameters to achieve both durability and avoidance of anticoagulation therapy

Inventive Principle:

Principle #35Parameter changes

3Reliability

If tissue engineered heart valve is used, then non-thrombogenic long term durability is achieved, but adaptability to somatic growth is limited

Engineering Contradiction:

Improvenon-thrombogenic long term durabilityVSAvoidadaptability to somatic growth

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent incorporates a balloon-expandable design that allows the valve to be deployed in a compressed state and then expanded to its full functional size. This dynamic deployment mechanism provides adaptability to different anatomical sizes and allows for minimally invasive delivery, while the biodegradable metal frame maintains structural integrity for long-term durability and thrombus resistance

Inventive Principle:

Principle #15Dynamics

4Adaptability or versatility

If biodegradable metal frame is used, then adaptability to somatic growth is improved, but manufacturing complexity increases

Engineering Contradiction:

Improveadaptability to somatic growthVSAvoidmanufacturing complexity

Core Design Contradiction:

Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The patent utilizes biodegradable metal alloys with specific compositional parameters (such as magnesium-based alloys with controlled impurities) that provide optimal balance between mechanical strength, biodegradability, and manufacturability. By carefully selecting and controlling the alloy parameters, the system achieves adaptability to somatic growth while managing manufacturing complexity through standardized alloy production processes

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20260053978A1Biodegradable Metallic - Polymeric Composite Prosthesis for Heart Valve Replacement

Publication Date: 2026.02.26 UNIVERSITY OF CINCINNATI

AI summary

Provided herein is a prosthetic heart valve device including a biocompatible and biodegradable metal frame comprising a proximal end, a distal end, and a sidewall therebetween, the sidewall having a plurality of openings therethrough. The device further includes a biocompatible and biodegradable polymeric heart valve having an annular portion attached at least one contact point to the proximal end of the frame and at least one leaflet attached to and extending distally from the annular portion.