Left Atrial Appendage Occlusion Device with Flexible Cap
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Solution Overview
Problem
Existing left atrial appendage occlusion devices, such as the Plaato and Watchman devices, have limitations in accommodating varying sizes and shapes of the left atrial appendage and securing the device effectively within the heart, which hinders their widespread acceptance and success.
Innovation Solution
A compliant cap device is positioned outside the ostium of the left atrial appendage, tethered to an anchoring bulb within the appendage, featuring multiple sail segments and wire loops that form a flexible, conformable structure to accommodate different heart chamber contours, preventing clot migration without attempting blood filtration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid membrane structure is used to span the left atrial appendage opening, then the device provides effective occlusion, but it cannot accommodate varying sizes and shapes of the appendage
Solution Approach 1:
The patent employs a flexible cap structure made of compliant material that can deform and conform to different anatomical configurations. This flexible cap replaces the rigid membrane, allowing the device to adapt to varying sizes and shapes of the left atrial appendage while maintaining effective occlusion through its ability to flex and conform to the specific anatomy.
Solution Approach 2:
The device incorporates dynamic elements including a compressible bulb and flexible cap that can change shape and volume in response to anatomical variations. The cap is designed to flex and conform dynamically to match the specific contours of each patient's left atrial appendage, enabling adaptation to different anatomical configurations while maintaining reliable occlusion.
2Reliability
If barbs or prongs are used to secure the device in the tissue, then the device is firmly anchored, but the device becomes more complex and may cause tissue damage
Solution Approach 1:
The patent removes the barbs or prongs from the device structure and replaces them with an alternative anchoring mechanism. The bulb is compressed to expel a protrusion that engages with the tissue, providing anchoring security without the complexity and tissue damage potential of traditional barbs or prongs. This extraction of the problematic element simplifies the device while maintaining reliability.
Solution Approach 2:
The device employs a disposable coating material applied to the bulb surface that facilitates tissue engagement and anchoring. This coating serves as a temporary, sacrificial element that enables secure placement without requiring complex mechanical anchoring structures, thereby reducing device complexity while maintaining anchoring security.
3Object-affected harmful factors
If an impervious membrane is used, then blood flow is completely blocked, but clots cannot be filtered and may still migrate
Solution Approach 1:
The patent employs a porous coating material on the bulb surface that allows selective passage of blood while trapping clots. The porous structure enables blood flow through the coating while the pore size and surface characteristics prevent clot migration, achieving both filtration and maintaining adequate blood flow without complete obstruction.
Solution Approach 2:
The device applies different functional properties to different parts of the structure. The cap provides complete occlusion with its impervious material, while the bulb coating provides selective filtration. This local differentiation of material properties allows the device to simultaneously prevent clot migration while maintaining adequate blood flow through the porous coating regions.
Data Source
AI summary
A medical device implant for the left atrial appendage of a patient's heart, to prevent strokes. The device includes a cap that overlies the opening of the LAA connected to a bulb in the LAA. Dis-continuous segmented sails attached to the cap promote tissue growth over the device.