Multi-Sharpness Soft Tissue Anchors for Left Atrial Appendage Occlusion
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Solution Overview
Problem
Existing medical devices for occluding the left atrial appendage in patients with atrial fibrillation are inadequate in effectively preventing thrombi formation and migration, leading to stroke or heart attack risks.
Innovation Solution
An occlusive implant with an expandable framework and radially extending anchor members, including branches with varying tip configurations for enhanced tissue penetration and anchoring, allowing for secure deployment and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing medical devices are used for occluding the left atrial appendage, then the device structure is relatively simple, but the effectiveness in preventing thrombi formation and migration is inadequate
Solution Approach 1:
The anchor member is divided into multiple branches (first branch with rounded tip, second branch with sharpened tip, third branch with sharpened tip) extending from a trunk portion. Each branch serves a specific function: the rounded tip branches provide smooth occlusion surfaces, while the sharpened tip branches enable effective tissue penetration. This segmentation allows the device to simultaneously achieve reliable thrombi prevention and manageable structural complexity.
Solution Approach 2:
Different tips of the anchor member branches are designed with different geometries (rounded vs. sharpened) to perform different local functions. The rounded tips are positioned to contact and occlude the left atrial appendage, while the sharpened tips are oriented to penetrate the tissue wall. This local differentiation of quality enhances the overall reliability of the device without requiring complete redesign of the entire structure.
2Reliability
If the anchor member has multiple branches with different tip configurations, then tissue penetration and anchoring are enhanced, but the device complexity increases
Solution Approach 1:
The anchor member is segmented into a trunk portion and multiple branches with different tip configurations. The first branch has a rounded tip for smooth occlusion, while the second and third branches have sharpened tips for tissue penetration. This segmentation enables each branch to perform its specific function effectively, achieving reliable anchoring without requiring an overly complex overall structure.
Solution Approach 2:
The branches are designed with asymmetric tip configurations rather than uniform geometry. The rounded tip of the first branch differs from the sharpened tips of the second and third branches. This asymmetry allows optimization of each branch for its specific function, improving tissue penetration and anchoring effectiveness while maintaining a relatively simple monolithic structure.
3Strength
If the implant is designed for secure deployment and retrieval, then the anchoring strength is improved, but the difficulty of retrieval operation increases
Solution Approach 1:
The anchor member is designed to be deflectable at the trunk portion, allowing it to change orientation during retrieval. The sharpened tips that provide strong anchoring during deployment can be deflected away from the sheath during retrieval, converting the same structural feature from a potential obstacle to a controllable element. This inversion of the anchoring mechanism's behavior during retrieval simplifies the operation.
Solution Approach 2:
The anchor member incorporates deflection capability at the trunk portion, making it a dynamic structure rather than a rigid one. During deployment, the anchor member extends and anchors firmly; during retrieval, the trunk portion can deflect to allow the branches to clear the sheath. This dynamic behavior enables strong anchoring while maintaining ease of retrieval operation.
Data Source
AI summary
An occlusive implant may include an expandable framework configured to shift between a collapsed configuration and an expanded configuration, the expandable framework including a proximal end and a distal end. The expandable framework includes a plurality of anchor members extending radially outward from the expandable framework in the expanded configuration, each anchor member including a root portion fixedly attached to the expandable framework and extending distally to a trunk portion in the expanded configuration. At least a portion of the trunk portion extends radially outward relative to the root portion in the expanded configuration. At least one of the plurality of anchor members includes a plurality of branches extending radially outward from the trunk portion in the expanded configuration.