LAA Occlusion Clip Applier Positioner for Secure Sealing
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Solution Overview
Problem
Current methods for occluding the left atrial appendage (LAA) in patients with atrial fibrillation are limited in their ability to securely and effectively seal the LAA orifice, which is crucial for reducing the risk of stroke and managing atrial fibrillation.
Innovation Solution
A system comprising a visualization tool, a clip applier, and an introducer is developed to allow for precise application of an occlusion clip on the LAA. The system includes a positioner to apply forces to the clip applier and occlusion clip, ensuring secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current occlusion methods are used to seal the LAA orifice, then the procedure can be performed with simpler devices, but the sealing effectiveness and security of occlusion is insufficient
Solution Approach 1:
The system is divided into distinct functional modules: a visualization tool with scope for visual guidance, a separate clip applier for precise clip application, and an introducer for navigation. This segmentation allows each component to be optimized for its specific function while working together to achieve reliable LAA occlusion.
Solution Approach 2:
The clip applier and occlusion clip are delivered through the introducer in a nested configuration, where the clip applier is positioned within the introducer's lumen, and the occlusion clip is loaded onto the clip applier. This nested delivery system enables minimally invasive access to the LAA while maintaining secure clip placement.
2Reliability
If a secure occlusion clip placement is achieved on the LAA, then the risk of stroke is reduced, but the precision required for clip application increases
Solution Approach 1:
The system performs preliminary actions by first advancing the visualization tool to obtain visual guidance of the LAA orifice, then positioning the introducer and clip applier under visual confirmation. The occlusion clip is pre-loaded onto the clip applier in an open state before delivery, ensuring proper positioning and orientation before application to the LAA.
Solution Approach 2:
The visualization tool provides real-time visual feedback during the entire procedure, allowing the operator to monitor the position of the introducer, clip applier, and occlusion clip as they are advanced toward the LAA orifice. This visual feedback enables precise positioning and confirmation of secure clip placement.
3Reliability
If the LAA is effectively excluded to manage atrial fibrillation, then patient outcomes improve, but the complexity of the procedural system increases
Solution Approach 1:
The system integrates multiple functions into a coordinated procedure: the visualization tool serves both for navigation and for confirming clip placement, the introducer facilitates both access and stabilization, and the clip applier enables both delivery and secure attachment of the occlusion device. This multi-functionality achieves effective LAA exclusion while managing system complexity through coordinated design.
Data Source
AI summary
An example system for applying an occlusion clip to an anatomical structure may include a visualization tool configured to allow visualization of an anatomical structure using a scope; a clip applier configured to apply an occlusion clip on the anatomical structure; an introducer connectable to the clip applier and configured to aid in positioning the clip applier; and a positioner configured to apply at least one of a linear force and a torsional force to at least one of the clip applier and the clip.