Shape Memory Foam Sealing Around Heart Valves With Paravalvular Leaks

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Conventional methods for sealing around implanted valves, such as Dacron skirts, fail to adequately fill the paravalvular space and promote tissue integration, leading to paravalvular leaks and poor device sealing.

Innovation Solution

The use of shape memory polymer (SMP) foams that expand radially to fill gaps around valves, promoting tissue integration and occluding leaks, with features like adhesion to valve support struts and controlled deployment mechanisms to prevent dislodgment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sealing methods (Dacron skirts) are used, then the device structure is simple, but the sealing effectiveness is insufficient and tissue integration is poor

Engineering Contradiction:

Improvesealing effectivenessVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes shape memory polymers that change their physical parameters (shape, volume, density) in response to temperature changes. The SMP foam transitions from a compressed low-density state during delivery to an expanded high-density state at body temperature, enabling effective sealing without complex mechanical structures

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material structures combining SMP foam with valve support struts and tissue integration features. The foam is adhered to the valve support structure, creating a composite system that provides both structural support and sealing functionality, resolving the contradiction between simplicity and effectiveness

Inventive Principle:

Principle #40Composite materials

2Reliability

If the foam expands radially to fill gaps, then sealing effectiveness improves, but shear forces during deployment increase

Engineering Contradiction:

Improvesealing effectivenessVSAvoidshear forces

Core Design Contradiction:

ReliabilityVSForce

Solution Approach 1:

The SMP foam is pre-compressed to a low-density state before deployment, allowing it to be delivered through catheters with minimal resistance. Upon deployment, the foam automatically expands to its high-density sealing configuration, reducing the need for high shear forces during the sealing process

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent exploits the phase transition of shape memory polymers from a compressed state to an expanded state triggered by body temperature. This phase transition enables the foam to fill paravalvular gaps effectively while minimizing deployment forces, as the expansion is driven by thermal energy rather than mechanical shear

Inventive Principle:

Principle #36Phase transitions

3Stability of the object's composition

If the foam is adhered to valve support struts, then device stability improves, but manufacturing complexity increases

Engineering Contradiction:

Improvedevice stabilityVSAvoidmanufacturing process

Core Design Contradiction:

Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

The patent combines the sealing foam with the valve support struts into an integrated assembly. The SMP foam is adhered to the struts, merging the sealing function with the structural support function, which improves device stability while the modular design maintains manufacturing feasibility

Inventive Principle:

Principle #5Merging (Combining)

4Reliability

If the foam density is increased for better sealing, then occlusion effectiveness improves, but crimping capability decreases

Engineering Contradiction:

Improveocclusion effectivenessVSAvoidcrimping capability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a dynamic density transformation where the SMP foam transitions from a low-density compressed state (easy to crimp and deliver) to a high-density expanded state (effective for sealing and occlusion). This dynamic property resolution allows the foam to satisfy both crimping capability and occlusion effectiveness requirements at different stages of the device lifecycle

Inventive Principle:

Principle #15Dynamics

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 SMP foams effectively seal paravalvular leaks by integrating with surrounding tissue, providing durable occlusion and preventing leaks, while minimizing shear forces during deployment.

Implementation Method 1

an open-cell polyurethane thermoset shape memory polymer (SMP) foam, the SMP foam being configured to expand from a compressed secondary state to an expanded primary state

Methodology Applied

Scientific EffectShape memory polymer expansion: Shape Memory Polymer

Implementation Method 2

features like adhesion to valve support struts

Methodology Applied

Scientific EffectAdhesion: Adhesive

Data Source

PatentUS12508127B2Shape memory polymer foams to seal space around valves

Publication Date: 2025.12.30 SHAPE MEMORY MEDICAL INC

AI summary

An embodiment includes individual SMP foams that radially expand and fill gaps around a heart valve that may be improperly seated, in an unusual cross section, or has poor apposition against a calcified lesion. Other embodiments are described herein.