Asymmetric LAA Occluder Layout for Stable Pulmonary Ridge Sealing
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Solution Overview
Problem
Existing occlusion devices for the left atrial appendage (LAA) face challenges in achieving consistent and stable anchoring, leading to potential thrombus formation and stroke risk due to stagnation zones and interference with surrounding heart structures.
Innovation Solution
The occlusion device features a collapsible and expandable design with an offset proximal disc and distal lobe configuration, variable stiffness zones, and radiopaque markers for precise positioning, ensuring smooth transition over the pulmonary ridge and minimizing thrombus formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional symmetric occlusion device is used, then the device structure is simple, but the device cannot achieve consistent and stable anchoring and may create stagnation zones leading to thrombus formation
Solution Approach 1:
The patent applies asymmetry by configuring the occlusion device with an offset proximal disc and distal lobe arrangement, where the proximal disc is offset from the distal lobe along the longitudinal axis. This asymmetric geometry prevents the formation of stagnation zones by eliminating symmetric flow patterns, thereby reducing thrombus formation risk while achieving stable anchoring through the offset configuration that distributes forces more effectively across the tissue interface.
Solution Approach 2:
The patent implements local quality through variable stiffness zones within the device structure. The proximal disc and distal lobe are constructed with different material properties or structural characteristics in different regions, allowing each zone to provide appropriate mechanical support and sealing characteristics locally. This enables consistent anchoring in specific areas while maintaining overall device functionality and reducing stagnation zones.
2Reliability
If the occlusion device covers the pulmonary ridge adequately, then sealing is improved, but the device may interfere with surrounding heart structures such as the mitral valve annulus
Solution Approach 1:
The asymmetric offset configuration of the proximal disc and distal lobe allows the device to achieve adequate coverage of the pulmonary ridge while maintaining safe clearance from surrounding structures. The offset arrangement creates a more favorable geometry that directs blood flow away from the device edges, improving sealing effectiveness without compromising adjacent heart structures like the mitral valve annulus.
Solution Approach 2:
The device incorporates local quality variations through differentiated structural characteristics in the proximal disc and distal lobe regions. The proximal disc is designed with specific dimensional properties and material characteristics optimized for sealing against the pulmonary ridge, while the distal lobe provides support and anchoring. This localized optimization ensures adequate sealing coverage while minimizing interference with surrounding cardiac anatomy.
3Object-generated harmful factors
If the device creates smooth transition over the pulmonary ridge, then stagnation zones are reduced, but the device requires precise positioning which increases complexity
Solution Approach 1:
The asymmetric offset geometry of the proximal disc and distal lobe inherently creates smoother blood flow transitions over the pulmonary ridge by eliminating symmetric flow separation zones. This design feature reduces stagnation zones and thrombus formation risk while the offset configuration itself serves as an intrinsic positioning guide, reducing the need for complex positioning mechanisms.
Solution Approach 2:
The patent incorporates radiopaque markers on the device structure that provide visual contrast during imaging procedures. These markers enable precise positioning and verification of device placement without requiring complex positioning mechanisms. The radiopaque markers allow operators to confirm optimal device positioning fluoroscopically, ensuring smooth transition over the pulmonary ridge while minimizing stagnation zones through accurate placement.
Data Source
AI summary
According to one aspect of the disclosure, a collapsible and expandable medical device for occluding a left atrial appendage (“LAA”), includes a proximal disc, a distal lobe, and a connecting member. The proximal disc may be configured to cover an ostium of the LAA in an implanted condition of the medical device. The distal lobe may be configured to be received within a cavity of the LAA in the implanted condition of the medical device. The distal lobe may include a central longitudinal axis extending therethrough in an expanded condition of the medical device. The connecting member may connect the proximal disc to the distal lobe. In the expanded condition of the medical device, the proximal disc may not be radially symmetric about the central longitudinal axis of the distal lobe.