Left Atrial Appendage Closure Mesh for Stable Sealing and Anchoring
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Solution Overview
Problem
Existing LAA closure devices face challenges in sealing off the irregularly shaped LAA orifice due to limited deformability and anchoring issues, failing to adapt to various anatomies and resulting in potential clot formation.
Innovation Solution
A left atrial appendage closure system with a design featuring a plurality of supporting struts and rods, bifurcating branches, and anchors, allowing for stable deployment and retrieval, and a delivery system with crimped hubs for efficient loading and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large number of balloons are inflated to occlude the left auricle, then the occlusion effect is improved, but the risk of balloon rupture and procedural complexity increase
Solution Approach 1:
The occlusion function is divided into multiple independent balloons (first balloon, second balloon, third balloon) that can be individually controlled and deployed. Each balloon targets a specific portion of the left auricle, allowing selective occlusion without requiring all balloons to be inflated simultaneously, thereby reducing complexity while maintaining effective occlusion.
Solution Approach 2:
The system allows dynamic control of balloon inflation and deflation through separate control mechanisms. Balloons can be inflated in sequence or simultaneously based on procedural needs, and can be deflated independently if complications arise. This dynamic control reduces the risk compared to a single large balloon while maintaining occlusion effectiveness.
2Reliability
If multiple balloons are used to occlude the left auricle, then the occlusion coverage is improved, but the risk of balloon rupture and procedural complexity increase
Solution Approach 1:
The occlusion task is segmented across multiple smaller balloons rather than one large balloon. Each balloon operates at lower pressure and smaller volume, reducing the stress on individual balloon walls and minimizing rupture risk while collectively providing comprehensive auricle occlusion.
Solution Approach 2:
The system incorporates safety mechanisms including gradual inflation capability and independent deflation control for each balloon. These preemptive safety features allow the operator to monitor balloon status and deflate individual balloons if signs of impending rupture appear, preventing catastrophic failure.
3Ease of operation
If conventional delivery systems are used for left auricle occlusion, then the procedural simplicity is maintained, but the precision of occlusion placement is insufficient
Solution Approach 1:
Each balloon is designed with specific geometric characteristics and inflation patterns tailored to target particular regions of the left auricle. The first balloon targets the superior aspect, the second targets the inferior aspect, and the third targets the lateral aspect. This localized approach ensures precise occlusion placement while maintaining relatively simple deployment procedures.
Solution Approach 2:
The delivery system incorporates guiding catheters and positioning mechanisms that act as intermediaries to accurately deliver and position the balloons within the left auricle. These intermediary tools facilitate precise placement without requiring complex manual manipulation, balancing procedural simplicity with placement accuracy.
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 system provides effective sealing and anchoring within the LAA, adapting to varying anatomies, reducing the risk of clot formation and improving deployment efficiency.
Implementation Method 1
an expandable occlusion balloon (100) positioned within the left atrial appendage (LAA) to occlude the left pulmonary vein (LPV)
Implementation Method 2
The delivery system includes a catheter (10) configured to navigate the catheter through the venous system to the left atrium
Data Source
Figure 1~3
Figure 4~6
Figure 7~9
AI summary
A left atrial appendage (LAA) closure (1) and a system (6) for delivering the LAA closure are disclosed. The LAA closure (1) includes supporting struts (11), wherein the supporting struts (11) are distributed peripherally around a first hub (10) and extend outward, the supporting strut (11) bifurcates at a first position (110) into a left branch (111) and a right branch (112). The left branch (111) of each supporting strut (11) and the right branch (112) of an adjacent supporting strut join each other at a second position (113) and extend distally to form a distal end. The LAA closure further includes a supporting rod (12) between adjacent supporting struts (11) which ensures stability, absence of irregular deformation and lateral slippage, of the LAA closure (1). With the supporting rods (12) between the adjacent supporting struts (11), the LAA closure (1) forms a dense mesh which imparts high overall strength of the LAA closure (1).