Shape Memory Foam LAA Closure for Reliable Occlusion
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Solution Overview
Problem
Existing medical devices for closing the left atrial appendage (LAA) have limitations, necessitating the development of alternative designs and manufacturing methods to effectively prevent thrombi formation and reduce the risk of stroke or heart attack.
Innovation Solution
A left atrial appendage closure (LAAC) device incorporating a shape memory polymer foam element that expands from a crimped configuration to an expanded configuration after delivery, featuring distinct sections with varying properties and lumens for material injection and device advancement, enhancing occlusion and sealing capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a shape memory polymer foam element is used to expand from crimped to expanded configuration, then the occlusion capability and sealing effectiveness are improved, but the device complexity increases
Solution Approach 1:
The shape memory polymer foam element changes its physical state from a crimped configuration to an expanded configuration through parameter changes (temperature, stress, or chemical triggers). This allows the same component to provide both compact delivery and effective occlusion, resolving the contradiction between reliable occlusion and device complexity.
Solution Approach 2:
The device transitions from a static crimped state during delivery to a dynamic expanded state at the target site. The shape memory foam's ability to dynamically change its configuration in response to environmental conditions enables effective occlusion while maintaining a simple delivery profile, thus resolving the technical contradiction.
2Reliability
If distinct sections with varying properties are incorporated in the foam element, then the sealing effectiveness is improved, but the manufacturing precision requirements increase
Solution Approach 1:
The foam element is designed with distinct sections having varying properties (e.g., different density, porosity, or expansion characteristics) tailored for specific functions. The proximal section may have properties optimized for sealing against the atrial wall, while the distal section may have properties for filling the appendage cavity. This local differentiation improves sealing effectiveness while the continuous foam structure simplifies manufacturing compared to assembling multiple discrete components.
Solution Approach 2:
The foam element functions as a composite structure with regions of varying material properties within a single continuous component. This allows different sections to perform specialized functions (sealing, filling, anchoring) while maintaining manufacturability through single-step foam formation processes, resolving the contradiction between sealing effectiveness and manufacturing precision.
3Adaptability or versatility
If lumens are added for material injection and device advancement, then the functionality and versatility are improved, but the device complexity increases
Solution Approach 1:
The tubular member with integrated lumens serves multiple functions: advancing the device through vasculature, injecting sealing materials into the foam element, and potentially providing structural support. By consolidating these functions into a single multi-lumen structure rather than separate components, the device achieves high versatility while managing complexity through functional integration.
Solution Approach 2:
The lumens are nested within the tubular member structure, with the delivery catheter and guidewire systems nested within the lumens. This nested configuration allows multiple functional elements to coexist in a compact arrangement, improving versatility without proportionally increasing overall device complexity.
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 LAAC device effectively occludes the LAA, allowing for precise material delivery and sealing, thereby reducing the risk of thrombi formation and minimizing impact on surrounding anatomy.
Implementation Method 1
a shape memory polymer foam element that is adapted to expand from a crimped configuration for delivery to an expanded configuration after delivery
Data Source
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 polymer foam element that is adapted to expand from a crimped configuration for delivery to an expanded configuration after delivery and that includes, in its expanded configuration, a distal face and a proximal face. A tubular member extends proximally from the shape memory polymer foam element and defines a lumen extending through the tubular member.