Left Atrial Appendage Occluder With Dual-Group Anchoring
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Solution Overview
Problem
Existing occlusion devices for the left atrial appendage (LAA) face challenges in maintaining stability and reducing the risk of embolization due to inconsistent engagement with surrounding tissue, leading to potential adverse events such as late pericardial effusion and migration.
Innovation Solution
The medical device incorporates a configuration with a proximal disk, a distal lobe, and multiple groups of stabilizing wires or members with hooked ends positioned at varying axial lengths along the lobe to enhance tissue engagement, including a first group near the distal face and a second group positioned more proximally, ensuring consistent anchoring and reducing motion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single group of stabilizing wires is used, then the device structure is simpler, but the anchoring consistency and resistance to embolization are insufficient
Solution Approach 1:
The stabilizing wires are divided into multiple groups (first group and second group) positioned at different locations along the distal lobe. This segmentation allows each group to engage with tissue at different axial positions, providing more consistent anchoring and reducing the risk of embolization while maintaining a manageable device structure through systematic arrangement.
2Reliability
If stabilizing wires are positioned closer to the distal face, then engagement with surrounding tissue is improved, but the device may be more susceptible to proximal motion
Solution Approach 1:
The solution transitions from a single-position anchoring approach to a multi-position anchoring approach along the axial dimension. By positioning stabilizing wire groups at different axial locations (first group near distal face, second group more proximally), the device achieves stable engagement in multiple dimensions, preventing both distal embolization and proximal migration.
3Reliability
If multiple groups of stabilizing wires at varying positions are used, then embolization resistance is improved, but the manufacturing complexity increases
Solution Approach 1:
Different groups of stabilizing wires are positioned at different local positions along the distal lobe according to specific functional requirements. The first group is positioned to engage tissue near the distal face for embolization prevention, while the second group is positioned more proximally to prevent migration. This localized quality distribution optimizes performance while maintaining manufacturing feasibility through standardized wire components.
Data Source
AI summary
A left atrial appendage (“LAA”) occluder may include a proximal disk configured to cover an ostium of the LAA, a distal lobe configured to be received within a cavity of the LAA, and a connecting member connecting the proximal disk to the distal lobe. The occluder may include first and second groups of stabilizing members having first and second engagement features, respectively, configured to engage tissue surrounding the LAA when the occluder is implanted. In an unbiased condition of the occluder, the distal lobe may have an axial length extending between a proximal face and a distal face of the distal lobe. The second engagement features may be positioned at least 33% of the axial length beyond the proximal face of the distal lobe, and the first engagement features may be positioned distal to the second engagement features.