Left Atrial Appendage Implant With Covered Tethered Occlusion
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Solution Overview
Problem
The left atrial appendage in patients with atrial fibrillation fails to contract properly, leading to stagnant blood pooling and thrombi formation, which can break loose and cause stroke or heart attack, and existing medical devices for occluding the appendage have limitations.
Innovation Solution
A medical device with an expandable framework and occlusive element, secured by anchor members, is deployed to occlude the left atrial appendage, featuring a porous mesh for endothelization and a tether system for precise positioning and release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the left atrial appendage is left open to allow blood flow, then normal cardiac function is maintained, but thrombi formation occurs due to stagnant blood pooling
Solution Approach 1:
The patent extracts the problematic left atrial appendage from the blood flow pathway by deploying an occlusive device that isolates the appendage lumen from circulating blood, thereby preventing thrombi formation while maintaining overall cardiac function
Solution Approach 2:
The device applies local occlusion only to the left atrial appendage while leaving the rest of the cardiac circulation unchanged, achieving thrombi prevention in the specific problematic area without affecting global blood flow dynamics
2Reliability
If a medical device is deployed to occlude the left atrial appendage, then thrombi formation is reduced, but device complexity increases
Solution Approach 1:
The occlusion device is divided into distinct functional segments including an expandable framework, occlusive element, anchor members, and tether system, allowing each component to perform its specific function while simplifying the overall design and deployment process
Solution Approach 2:
The device transitions from a compressed delivery state to an expanded deployed state, with the framework expanding radially to engage the appendage wall and the occlusive element deploying to seal the lumen, providing adaptability to various anatomical configurations
3Reliability
If the left atrial appendage has complex geometry with large irregular surface areas, then cardiac function is maintained, but flow resistance increases leading to thrombi formation
Solution Approach 1:
The occlusive element functions as a flexible membrane that conforms to the irregular internal geometry of the left atrial appendage, creating an effective seal across the complex shaped lumen while allowing the device to adapt to variations in appendage morphology
Solution Approach 2:
The device addresses the complex three-dimensional geometry of the appendage by deploying structures that extend in multiple dimensions, with the framework providing radial expansion and the occlusive element creating a dimensional barrier to blood flow within the irregular space
Data Source
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AI summary
A system (100) for occluding a left atrial appendage comprises: a delivery device including an outer sheath (110) and an inner elongate member (130) slidably disposed within a lumen (120) of the outer sheath; an implant (200) for occluding a left atrial appendage (50), the implant comprising: an expandable framework (210) configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable framework includes an attachment point (240) configured to secure the expandable framework to the delivery device; and an occlusive element (290) disposed on a proximal portion of the expandable framework, wherein the occlusive element covers the attachment point; and a tether (140) extending longitudinally within the inner elongate member, the tether engaging the attachment point in a delivery configuration, wherein the attachment point includes a cam member (224) extending laterally across a proximal hub (220) of the expandable framework, wherein the cam member is configured to cooperate with a distal end of the inner elongate member, wherein the tether extends around the cam member, such that axial translation of the tether is configured to angle the expandable framework relative to a central longitudinal axis of the delivery device.