Shape Memory Foam Attachment for Conformal LAA Closure Sealing

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Solution Overview

Problem

Existing medical devices for closing the left atrial appendage (LAA) face challenges in effectively preventing thrombi formation and migration, with a need for alternative designs and manufacturing methods to enhance sealing and anchoring within the LAA.

Innovation Solution

Incorporating a shape memory foam component into medical devices, such as LAAC devices, by applying a foamable solution that transitions through pre-foam, mid-foam, and final foam states, allowing for secure attachment and expansion to conform to the LAA anatomy, providing a seal without damaging surrounding tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If a shape memory foam component is applied to the first component during the pre-foam state, then the foam has sufficient time to expand and conform to the LAA anatomy, but the reaction time is extended and manufacturing complexity increases

Engineering Contradiction:
Improveconformity to LAA anatomyVSAvoidmanufacturing process complexity
Core Design Contradiction:
ShapeVSDevice complexity

Solution Approach 1:

The foamable solution is applied to the first component in a pre-foam state before full expansion occurs. This preliminary application allows the foam to be positioned and conform to the LAA anatomy gradually as it expands in situ, rather than requiring pre-formed complex shapes that would increase manufacturing complexity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes the changing physical and chemical parameters of the foamable solution as it transitions through pre-foam, mid-foam, and final foam states. By applying the solution in the pre-foam state and allowing it to expand in place, the manufacturing process leverages natural parameter changes (volume expansion, viscosity increase) to achieve anatomical conformity without complex pre-forming steps

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If the foamable solution is applied during the mid-foam state, then the reaction progress is controlled, but the expansion capability and conformability to anatomy are reduced

Engineering Contradiction:
Improvereaction controlVSAvoidexpansion and conformability
Core Design Contradiction:
Manufacturing precisionVSShape

Solution Approach 1:

The foamable solution is applied in the pre-foam state (before mid-foam state) to maintain maximum expansion capability. This timing allows the foam to expand fully and conform to the LAA anatomy in situ, rather than limiting expansion by applying at the mid-foam state when expansion capability is already reduced

Inventive Principle:
Principle #10Preliminary action

3Stability of the object's composition

If the foamable solution is applied during the final foam state, then the reaction is complete and structural stability is achieved, but the ability to expand and conform to anatomy is lost

Engineering Contradiction:
Improvestructural stabilityVSAvoidexpansion and conformability
Core Design Contradiction:
Stability of the object's compositionVSShape

Solution Approach 1:

The foamable solution is applied in the pre-foam state, well before the final foam state, to preserve expansion capability during application. The foam then expands in situ to achieve both anatomical conformity and final structural stability, rather than applying pre-formed foam that has already lost expansion capability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs a dynamic approach where the foamable solution transitions through different states (pre-foam, mid-foam, final foam) in situ after application. This allows the material to be applied in a flexible, expandable state and then dynamically transform to achieve both conformability and structural stability in the final configuration

Inventive Principle:
Principle #15Dynamics

4Strength

If a binding solution is applied prior to the foamable solution, then adhesion to the first component is improved, but the manufacturing process steps increase

Engineering Contradiction:
Improveadhesion strengthVSAvoidnumber of process steps
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The binding solution and foamable solution are combined into a single integrated solution. The foamable solution includes both binding agents for adhesion to the first component and blowing agents for foam expansion. This merging eliminates the need for separate application steps, reducing manufacturing complexity while maintaining strong adhesion

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The foamable solution serves multiple functions simultaneously: it acts as a binding solution for adhesion to the first component, as a foam precursor for expansion and conformability, and as a sealing material for the LAA. This multi-functionality reduces the number of separate materials and process steps required

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 shape memory foam component enhances the sealing and anchoring capabilities of LAAC devices, reducing thrombi escape and improving the device's compatibility with the LAA anatomy, thereby minimizing stroke and heart attack risks.

Implementation Method 1

forming a foamable solution that over time progresses from an initial liquid pre-foam state to a subsequent mid-foam state in which the foamable solution is partially reacted and to a final foam state in which the foamable solution is fully reacted

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Implementation Method 2

The foamable solution is applied to the first component during one of the liquid pre-foam state, the subsequent mid-foam state and the final foam state

Methodology Applied
Scientific EffectPhase transition: Phase Change

Implementation Method 3

Incorporating a shape memory foam component into medical devices, such as LAAC devices, by applying a foamable solution that transitions through pre-foam, mid-foam, and final foam states, allowing for secure attachment and expansion to conform to the LAA anatomy

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Polymer

Data Source

PatentUS20250380947A1Methods for making medical devices that include a shape memory foam component
Publication Date: 2025.12.18 BOSTON SCIENTIFIC SCIMED INC
  • US20250380947A1 patent drawing
  • US20250380947A1 patent drawing
  • US20250380947A1 patent drawing

AI summary

A medical device may include a first component and a shape memory foam component that is secured relative to the first component. The medical device may be formed by forming a foamable solution that over time progresses from an initial liquid pre-foam state to a subsequent mid-foam state in which the foamable solution is partially reacted and to a final foam state in which the foamable solution is fully reacted and then applying the foamable solution to the first component during one of the liquid pre-foam state, the subsequent mid-foam state and the final foam state.