Shape Memory Foam LAAC Devices for Stable LAA Occlusion

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Solution Overview

Problem

Existing medical devices for occluding the left atrial appendage (LAA) have limitations in maintaining a stable closure and preventing thrombi formation, as they may deform under physiological conditions such as heart beating and blood flow, leading to potential thromboembolic events.

Innovation Solution

The use of a shape memory foam occlusive element with a reinforcing member that limits deformation, ensuring stable expansion and anchoring within the LAA, combined with a deformable device body and control structure to maintain occlusion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a shape memory foam occlusive element is used to expand and occlude the LAA, then the device can achieve stable occlusion and reduce thrombi formation, but the foam may deform under physiological conditions such as heart beating and blood flow

Engineering Contradiction:

Improveocclusion stabilityVSAvoidfoam deformation

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent combines shape memory foam with a reinforcing member to create a composite structure. The foam provides occlusion and conformability to the LAA geometry, while the reinforcing member prevents deformation under physiological conditions. This composite approach resolves the contradiction by integrating materials with complementary properties.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The reinforcing member is strategically positioned within the foam structure to provide localized support where deformation is most likely to occur. This allows the foam to maintain its occlusion function while the reinforcing member prevents excessive deformation under heart beating and blood flow forces.

Inventive Principle:

Principle #3Local quality

2Adaptability or versatility

If the shape memory foam is made deformable to accommodate LAA geometry, then it can expand effectively, but it cannot maintain structural integrity under physiological conditions

Engineering Contradiction:

Improveexpansion capabilityVSAvoidstructural integrity

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The patent uses a composite structure where the shape memory foam provides adaptability and expansion capability, while the reinforcing member provides structural integrity. The combination allows the device to both expand effectively into the LAA and maintain its shape under physiological conditions.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The shape memory foam undergoes parameter changes (expansion) when deployed into the LAA, transforming from a compressed delivery state to an expanded occlusion state. The reinforcing member is designed to maintain structural integrity during this transition and under subsequent physiological conditions.

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If a reinforcing member is added to limit foam deformation, then structural stability is improved, but device complexity increases

Engineering Contradiction:

Improvedeformation controlVSAvoiddevice structure

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

Rather than making the entire device complex, the reinforcing member is strategically positioned only where needed to prevent deformation. This localized approach provides deformation control while minimizing the increase in overall device complexity.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The reinforcing member can be integrated with the foam through various methods (adhesive bonding, mechanical interlocking, or co-extrusion) to create a unified composite structure. This integration reduces the practical complexity of assembly while maintaining the benefits of the reinforcing member.

Inventive Principle:

Principle #40Composite materials

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 solution provides a stable and effective occlusion of the LAA, reducing the risk of thrombi formation and associated complications by maintaining device integrity under physiological conditions.

Implementation Method 1

a shape memory foam occlusive element that is adapted to expand from a crimped configuration for delivery to an expanded configuration after delivery

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Polymer

Implementation Method 2

A reinforcing member is disposed relative to the shape memory foam occlusive element and is adapted to limit deformation of the shape memory foam occlusive element after the shape memory foam occlusive element has expanded into the expanded configuration

Methodology Applied

Scientific EffectMechanical constraint: Mechanical Force

Data Source

PatentUS20250331863A1Systems for occluding a left atrial appendage

Publication Date: 2025.10.30 BOSTON SCIENTIFIC SCIMED INC

AI summary

A left atrial appendage closure (LAAC) device is adapted for occluding a patient's left atrial appendage (LAA). The LAAC device includes a shape memory foam occlusive element that is adapted to expand from a crimped configuration for delivery to an expanded configuration after deployment, the shape memory foam occlusive element including in its expanded configuration a distal face, a proximal face and an intervening periphery. A reinforcing member is disposed relative to the shape memory foam occlusive element and is adapted to limit deformation of the shape memory foam occlusive element after the shape memory foam occlusive element has expanded into the expanded configuration.