Atrial Appendage Occluder with Semi-Release Control Mechanism
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Solution Overview
Problem
Current atrial appendage occluders lack adjustability, leading to poor positioning accuracy and increased risk of adverse events such as puncture and tear during surgical procedures due to their one-step release mechanism and barbed structure.
Innovation Solution
An atrial appendage occluder capable of entering a semi-release state by pushing a distal cable, featuring a woven mesh occluder body connected to control cables, allowing for adjustable size and position adjustment within the atrial appendage to ensure accurate release at an intended occlusion position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a one-step release mechanism is used for the occluder, then the device structure is simple, but the positioning accuracy is poor and the occluder cannot be adjusted to match the atrial appendage anatomy
Solution Approach 1:
The release mechanism is segmented into two distinct stages: a first release stage that partially deploys the occluder body to a first configuration, and a second release stage that completes the deployment to a second configuration. This segmentation allows the operator to pause between stages to assess positioning accuracy and make adjustments if needed, resolving the contradiction between simple structure and precise positioning.
Solution Approach 2:
The occluder body is designed with dynamic configurability, transitioning from a compressed first configuration during delivery to an expanded second configuration at the deployment site. This dynamic transformation enables the device to adapt to the specific anatomy of the atrial appendage, improving positioning accuracy while maintaining a relatively simple overall structure through controlled morphing.
2Reliability
If the occluder is released completely in one step, then the operation is fast, but the risk of puncture and tear increases due to inability to adjust position
Solution Approach 1:
The first release stage performs a preliminary deployment of the occluder body to a partially expanded first configuration, allowing the operator to verify positioning before complete deployment. This preliminary action reduces the risk of puncture and tear by enabling position verification, while the rapid two-stage process maintains overall surgical efficiency.
Solution Approach 2:
The release process is divided into partial (first release stage) and complete (second release stage) actions. The first stage provides sufficient partial deployment to assess positioning and make adjustments if needed, reducing adverse event risk. The second stage completes the deployment rapidly, balancing safety with surgical productivity.
3Manufacturing precision
If the occluder is withdrawn and released again due to improper positioning, then the positioning accuracy can be improved, but the risk of puncture and tear increases due to repeated release
Solution Approach 1:
The two-stage release mechanism eliminates the need for complete withdrawal and re-release by providing an intermediate first configuration that allows positioning verification. If adjustment is needed, the operator can manipulate the delivery catheter to reposition the occluder while it remains in the first configuration, then proceed to the second release stage, avoiding repeated full releases and reducing puncture and tear risk.
Solution Approach 2:
The dynamic first configuration serves as a safety checkpoint, allowing the operator to assess positioning and make adjustments before committing to the final second configuration. This dynamic intermediate state prevents the need for repeated releases, thereby reducing the cumulative risk of puncture and tear while maintaining high positioning accuracy.
4Strength
If a barbed structure is used on the occluder, then the anchoring strength is improved, but the risk of puncture and tear increases during repeated release
Solution Approach 1:
The barbed structure is designed to engage the atrial appendage tissue during the transition from the first configuration to the second configuration, rather than during delivery or repeated release attempts. The first release stage positions the occluder without full barbed engagement, allowing verification before the barbs deploy during the second stage, thereby reducing puncture and tear risk while maintaining anchoring strength.
Solution Approach 2:
The barbed structure's engagement is made dynamic and conditional: the barbs remain retracted or less engaged during the first configuration and delivery phase, then engage fully during the transition to the second configuration after positioning is confirmed. This dynamic engagement reduces harmful puncture and tear effects during positioning while maintaining necessary anchoring strength for the final occlusion.
Data Source
AI summary
An atrial appendage occluder capable of entering a half-released state by means of pushing a head-end fiber comprises: an occlude body (1); a head-end control fiber (2); and a tail-end control fiber (3). A head end of the occluder body (1) is connected to one end of the head-end control fiber (2) by means of a head-end threaded bushing (4). A tail end of the occluder body (1) is connected to one end of the tail-end control fiber (3) by means of a tail-end threaded bushing (5). The tail-end control fiber (3) is in the form of a hollow column. The other end of the head-end control fiber (2) sequentially passes through the tail-end threaded bushing (5) and the tail-end control fiber (3). The occluder body (1) is in a woven-net support structure, and has a shape preconfigured to match the structure of an atrial appendage after the occluder body (1) has been fully released. The occluder body (1) is in the form of a strip and disposed in an outer sheath (6) before being released. The occluder body (1) is in a half-release state after being pushed out of the outer sheath (6). The diameter of the occluder body (1) is changed by pushing or pulling the head-end control fiber (2, 3). The atrial appendage occluder can adjust its location in the atrial appendage, such that the occluder can be released precisely in a preset location.