Left Atrial Appendage Occluder With Actuatable Tissue Fixation
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Solution Overview
Problem
The left atrial appendage in patients with atrial fibrillation experiences stagnant blood pooling, leading to thrombus formation and potential thromboembolic events due to irregular contractions, which existing medical devices have not adequately addressed.
Innovation Solution
A medical device with an expandable member and fixation members that expand to seal the left atrial appendage ostium, featuring a valve member and a retention sheath, allowing the fixation members to engage tissue and promote endothelial growth, effectively occluding the appendage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fixation members are made actuable to engage tissue, then device reliability is improved, but device complexity increases
Solution Approach 1:
The fixation members are designed to be actuable between a retracted configuration during delivery and an extended configuration upon deployment. This dynamic capability allows the same structure to serve different functions at different stages, improving reliability without permanently increasing complexity
Solution Approach 2:
The fixation members are pre-positioned in a retracted state within the expandable member during delivery, and automatically extend to engage tissue upon expansion. This preliminary positioning eliminates the need for separate delivery and fixation mechanisms, resolving the contradiction between reliability and complexity
2Object-affected harmful factors
If the expandable member is used to seal the left atrial appendage ostium, then thrombus formation is reduced, but the risk of incomplete occlusion increases
Solution Approach 1:
The occlusion system is divided into two functional segments: the expandable member for initial sealing and the actuable fixation members for definitive engagement. This segmentation allows each component to perform its specialized function, ensuring complete occlusion while reducing thrombus formation risk
Solution Approach 2:
The occlusion process continues sequentially through two stages: first the expandable member seals the ostium, then the fixation members engage the tissue to maintain the seal. This continuous action ensures complete and reliable occlusion, eliminating the risk of incomplete sealing
3Ease of operation
If fixation members are biased into the delivery configuration, then ease of delivery is improved, but fixation strength during deployment may be compromised
Solution Approach 1:
The fixation members are designed with a dynamic configuration that allows them to be biased into a retracted state for easy delivery through the vasculature, then automatically extend to their full fixation length upon deployment. This dynamic behavior resolves the contradiction by providing the appropriate configuration at the appropriate time
Solution Approach 2:
The length and position of the fixation members change as a function of the expandable member's expansion state. During delivery, the members are compressed to a shorter effective length for ease of passage; upon deployment, they extend to their full length to provide maximum fixation strength, thus resolving the contradiction through parameter transformation
Data Source
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AI summary
An example medical device for occluding the left atrial appendage is disclosed. The example medical device for occluding the left atrial appendage includes an expandable member having a first end region, a second end region and an inflation cavity. The example medical device includes at least one fixation member having a first end and a second end coupled to the expandable member. The at least one fixation member is configured to move from a delivery configuration to a deployed configuration in response to an expansion of the expandable member. Additionally, the example medical device includes a valve member extending at least partially into the inflation cavity and the expandable member is configured to expand and seal the opening of the left atrial appendage.