Expandable Heart Valve Leaflets for Pediatric Growth

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Solution Overview

Problem

Congenital heart valve diseases often result in improperly formed aortic or pulmonary valves, leading to issues such as defective tissue leaflets, improper coaptation, and valve stenosis or regurgitation, necessitating multiple surgeries as patients grow, which are costly and risky.

Innovation Solution

Development of an artificial heart valve with a self-expanding frame and leaflets that grow with the patient, incorporating embedded support structures like nickel titanium alloys and undulating meshes, allowing the valve to accommodate anatomical changes without requiring additional surgeries.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a traditional fixed-size heart valve is implanted, then the valve structure is simple and easy to manufacture, but the valve cannot accommodate patient growth requiring multiple surgeries

Engineering Contradiction:

Improvevalve size adaptabilityVSAvoidvalve structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The heart valve is designed with dynamic characteristics, allowing it to expand and grow along with the patient's anatomy. The frame and leaflets are configured to transition from an initial size suitable for infants to a larger size as the patient grows, eliminating the need for multiple replacement surgeries.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The valve employs parameter changes in its structural properties, specifically utilizing materials and designs that allow the frame and leaflets to change size. The embedded support structures enable controlled expansion while maintaining structural integrity throughout the growth process.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If multiple surgeries are performed to replace valves as patients grow, then the valve size can be matched to patient needs, but healthcare costs and surgical risks increase

Engineering Contradiction:

Improvevalve function reliabilityVSAvoidtime lost to multiple surgeries

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The valve is designed with preliminary growth capacity built in from the outset. By anticipating future anatomical growth and incorporating expandable features in the initial implant, the system prevents the need for subsequent surgical interventions to accommodate size changes.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The heart valve performs self-adjustment through its inherent growth mechanism, automatically adapting to the patient's anatomical changes without requiring external surgical intervention. The embedded support structures enable the valve to self-expand as the patient grows.

Inventive Principle:

Principle #25Self-service

3Adaptability or versatility

If the frame and leaflets are made expandable to accommodate growth, then the valve can grow with the patient, but the manufacturing complexity increases

Engineering Contradiction:

Improvevalve growth capabilityVSAvoidvalve manufacturing ease

Core Design Contradiction:

Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The valve employs composite material construction, combining flexible materials for the frame and leaflets with embedded rigid support structures. This composite approach enables the valve to be manufactured with growth capabilities while maintaining structural integrity and functionality throughout expansion.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The valve design incorporates nested structures where the leaflets are positioned within or alongside the frame, and embedded support structures are integrated within the valve components. This nesting allows for compact manufacturing while enabling expansion through coordinated deployment of nested elements.

Inventive Principle:

Principle #7Nested doll (Nesting)

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 self-growing valve maintains proper function as the patient grows, reducing the need for multiple surgeries, lowering healthcare costs and emotional stress, and ensuring consistent blood flow regulation.

Implementation Method 1

an embedded support structure that expands with expansion of the frame and contracts with contraction of the frame

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Implementation Method 2

the embedded support structure comprises an undulating mesh

Methodology Applied

Scientific EffectGeometric transformation: Geometry

Data Source

PatentUS20260069441A1Self-growing heart valves

Publication Date: 2026.03.12 EDWARDS LIFESCIENCES CORP

AI summary

Described herein are artificial valves that have a frame and leaflets that grow or expand with a patient. Upon placing the valve inside the patient, the valve expands as the annulus of the patient expands. The frame of the valve is configured to expand which in turn causes the leaflets to expand (e.g., to grow). The valve includes a thin undulating wire embedded inside the leaflets. As the annulus of the patient grows, the frame expands, and as the frame expands, the leaflets grow. The growth or expansion of the leaflets is configured so that the valve continues to operate properly (e.g., the leaflets continue to coapt) with expansion of the annulus. The change in size of the valve can be configured to accommodate changes in size of the annulus from an infant or child to an adult.