Expandable LAA Occlusion Frame With Volume-Filling Foam
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Solution Overview
Problem
Existing medical devices for occluding the left atrial appendage (LAA) have limitations and an ongoing need for alternative designs and methods to effectively prevent thrombi formation and reduce the risk of stroke or heart attack.
Innovation Solution
A system and method involving an expandable frame and expandable elements, such as foam blocks or shape memory foam, that are deployed to occlude the LAA, with the elements expanding after delivery to fill the appendage volume, providing a comprehensive occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional LAAC devices are used to occlude the left atrial appendage, then the device structure is relatively simple and easy to manufacture, but the occlusion effectiveness is insufficient and may leave stagnant blood volumes
Solution Approach 1:
The occlusion device is divided into multiple segments: an expandable frame structure and multiple separate expandable elements (foam blocks). The frame provides the structural scaffold while the individual foam elements can be independently deployed to fill different regions of the LAA, allowing comprehensive occlusion of complex anatomical shapes without requiring a single complex monolithic structure
Solution Approach 2:
The expandable foam elements are delivered within the expandable frame structure in a nested configuration. The foam elements are contained within the frame's delivery configuration and are sequentially deployed into the LAA cavity, with each foam block nested within the overall frame structure, enabling compact delivery followed by progressive expansion to fill the appendage
2Adaptability or versatility
If the LAA is occluded with a fixed structure, then the device is simple to deploy, but it cannot adapt to varying LAA sizes and shapes across different patients
Solution Approach 1:
Both the frame and foam elements are designed with dynamic expandability. The frame expands from a compressed delivery state to a larger deployed configuration, and the foam elements similarly expand from compact forms to larger volume-filling structures. This dynamic expansion capability allows the device to adapt to varying LAA sizes and shapes while maintaining a simple compressed delivery profile
Solution Approach 2:
The device utilizes parameter changes in the foam material properties, specifically transitioning from a compressed low-volume state to an expanded high-volume state. The foam elements can be delivered in a compressed configuration that fits within the delivery catheter, then expand in situ to fill the LAA cavity, adapting to the specific anatomical parameters of each patient's appendage
3Length of moving object
If expandable foam elements are delivered in compressed configuration, then the delivery profile is reduced, but the expansion process adds time and complexity to the procedure
Solution Approach 1:
The foam elements are pre-compressed into compact configurations suitable for delivery through the catheter system. This preliminary compression allows the elements to be loaded into the delivery system in advance, and upon deployment, they automatically expand to their functional volume-filling configuration, reducing the need for complex post-deployment manipulation
Solution Approach 2:
The expansion of the foam elements is achieved through pneumatic or hydraulic mechanisms integrated into the delivery system. Compressed gas or fluid is used to inflate the foam elements from their compressed delivery state to their expanded functional state, enabling rapid expansion without requiring manual manipulation or complex mechanical assembly steps
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 system effectively occludes the LAA, preventing thrombi formation by filling the appendage volume with expandable elements that convert to native tissue, ensuring no stagnant blood remains, thereby reducing the risk of clot migration and associated cardiovascular events.
Implementation Method 1
at least some of the one or more expandable elements may include expandable foam blocks adapted to be delivered in a compressed configuration and to expand once delivered into the expanded configuration
Implementation Method 2
the liquid may include a liquid foam
Implementation Method 3
the liquid may include a hydrogel
Implementation Method 4
the one or more expandable elements may include a shape memory foam plug shaped to facilitate extending the shape memory foam plug through the expandable frame
Data Source
AI summary
A system for occluding a patient's left atrial appendage (LAA) includes an expandable frame and one or more expandable elements. The expandable frame is moveable from a collapsed delivery configuration to an expanded deployment configuration in which the expandable frame is adapted to span across at least a portion of the LAA, the expandable frame defining an LAA volume distal of the expandable frame once deployed. The one or more expandable elements are adapted to be deployed behind the expandable frame in order to fill at least part of the LAA volume distal of the expandable frame, each of the one or more expandable elements adapted to expand subsequent to delivery.