LAA Occluder Foam Laminate for Uniform Occlusion Thickness

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Solution Overview

Problem

Current occluder devices for left atrial appendages face challenges due to anatomical variability, inconsistent thickness of occlusive materials, and complex manual processes in forming ePTFE laminates, leading to inconsistent performance and inadequate occlusion.

Innovation Solution

A medical device with a framework and occluder member featuring a seamless, monolithic foam portion and a polymeric laminate, formed using controlled pressure and temperature processes to ensure consistent thickness and structural integrity, along with a pivotable anchor frame for adjustable deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If manual processes are used to form three-dimensional shape from sheet material, then the occlusive material can be attached to the framework, but the process is tedious and results in inconsistencies in thickness

Engineering Contradiction:

Improveease of forming occlusive materialVSAvoidconsistency of occlusive material thickness

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent replaces manual mechanical processes with automated molding technology. The occlusive material is formed using a molding process that automatically creates the three-dimensional shape and attaches it to the framework, eliminating the tedious manual operations while ensuring consistent thickness throughout the material.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the manufacturing parameters by using controlled molding conditions (temperature, pressure, time) to form the occlusive material. This allows precise control over the thickness and dimensional consistency of the material, achieving uniform properties that cannot be obtained through manual processes.

Inventive Principle:

Principle #35Parameter changes

2Ease of manufacture

If ePTFE laminate is formed by stacking multiple layers under compressive force and heat, then the laminate can be created, but varying thicknesses result in inconsistent compressive force and temperature distribution

Engineering Contradiction:

Improveease of forming ePTFE laminateVSAvoiduniformity of compressive force and temperature

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent uses a flexible membrane or thin film as a tooling element during the molding process. This flexible element conforms to the framework geometry and ensures uniform distribution of compressive force and temperature across the occlusive material, even when forming complex three-dimensional shapes with varying thickness requirements.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent replaces the traditional stacking and compression method with a direct molding process. Instead of manually stacking multiple ePTFE layers and applying compressive force, the material is formed in a mold that automatically applies uniform pressure and heat, eliminating the inconsistencies associated with manual layer stacking.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Ease of manufacture

If current implantable devices are designed with fixed structure, then manufacturing is simplified, but the devices cannot meet the wide variability of ostium size and volume

Engineering Contradiction:

Improvesimplicity of device structureVSAvoidadaptability to anatomical variability

Core Design Contradiction:

Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent divides the occlusive material into multiple segments or zones with different thicknesses and properties. Each segment can be independently optimized for specific anatomical regions, allowing the device to adapt to varying ostium sizes and shapes while maintaining a relatively simple overall structure that can be manufactured using standardized molding processes.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent creates an occlusive material with dynamic characteristics, where the thickness and structural properties vary continuously to match the anatomical geometry. This dynamic design allows the device to adapt to different patient anatomies while being formed through a controlled molding process that can produce customized geometries.

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 solution provides consistent occlusion across varying anatomical structures, enhances tissue integration, and improves the effectiveness of occlusive materials by ensuring uniform thickness and structural consistency.

Implementation Method 1

elevating a temperature of the stacked polymer film structure

Methodology Applied

Scientific EffectHeat: Heating

Implementation Method 2

applying pressure to a top surface of the stacked polymer film structure

Methodology Applied

Scientific EffectPressure: Compression

Data Source

PatentUS12533138B2Occlusive material for medical device, system, and method thereof

Publication Date: 2026.01.27 COHEREX MEDICAL INC

AI summary

Medical devices, systems and methods for forming an occlusive material for occluding a left atrial appendage of a heart are provided. In one embodiment, the occlusive material includes a foam portion that extends as a single piece, seamless monolithic structure that is sized to couple to an external side of a framework of a medical device. In another embodiment, the occlusive material may include a polymeric laminate. Such polymeric laminate may be adhered to an outer side of the foam portion. Further, various embodiments for forming a polymer laminate are provided.