Dual-Layer Mesh Aneurysm Occluder for Large-Neck Sac Coverage
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Solution Overview
Problem
Existing treatments for aneurysms, such as coil embolization and stent placement, are invasive, time-consuming, and can lead to complications like brain swelling, thrombosis, and stroke, while traditional embolic devices may not effectively occlude large aneurysms or require additional medications, limiting their use in ruptured aneurysms.
Innovation Solution
Development of an embolic device with a dual-layer mesh structure that expands within the aneurysm to securely cover the neck and sac, featuring a D-shaped element with a self-expanding design for precise placement and enhanced anchoring, allowing for efficient occlusion without the need for additional medications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional embolic devices are used to treat aneurysms, then occlusion can be achieved, but the devices may not effectively occlude large aneurysms and require additional medications
Solution Approach 1:
The device employs a nested structure where an inner mesh tube is contained within an outer mesh tube, allowing the device to achieve sufficient radial expansion and occlusion force for large aneurysms while maintaining deliverability through standard catheters. The nested configuration enables the device to scale its occlusion capability to match aneurysm size.
Solution Approach 2:
The embolic device is divided into segmented mesh tubes with specific structural characteristics - the inner mesh tube has a first structural characteristic and the outer mesh tube has a second structural characteristic. This segmentation allows each layer to contribute differently to the overall occlusion mechanism, enabling effective treatment of large aneurysms without requiring additional medications.
2Reliability
If coil embolization is used to treat aneurysms, then occlusion can be achieved, but the procedure is invasive and time-consuming
Solution Approach 1:
The device is pre-configured with a specific geometric relationship between the inner and outer mesh tubes before delivery. The inversion fold is pre-formed at a predetermined location, and the radial expansion capability is built into the structure. This preliminary configuration allows for rapid deployment and occlusion without requiring time-consuming procedural steps.
3Strength
If stent placement is used to treat aneurysms, then structural support can be provided, but complications like brain swelling and thrombosis can occur
Solution Approach 1:
The device utilizes porous mesh tube structures for both the inner and outer layers. This porosity allows for controlled blood flow and reduces the risk of thrombosis while maintaining sufficient structural support for aneurysm occlusion. The mesh configuration provides structural strength without causing the harmful complications associated with solid stent placement.
4Reliability
If multiple coils or additional procedures are used to treat aneurysms, then occlusion can be achieved, but the treatment becomes more invasive
Solution Approach 1:
The invention merges the functions of multiple embolic elements into a single integrated device consisting of an inner mesh tube and an outer mesh tube. This unified structure provides complete occlusion capability in one device, eliminating the need for multiple separate coils or additional procedures while maintaining occlusion effectiveness.
Data Source
AI summary
An apparatus for treating an aneurysm includes an occlusion element configured to be releasably coupled to an elongate delivery shaft and having a distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end, the occlusion element configured to be delivered in a collapsed configuration and further configured to expand to an expanded configuration, the occlusion element comprising an inverted mesh tube having an outer layer and an inner layer, the outer layer transitioning to the inner layer at an inversion fold located at or adjacent the distal end of the occlusion element, the inversion fold defining an inner diameter, the occlusion element further comprising a maximum outer diameter, wherein the inner diameter is between about 35% to about 85% of the maximum outer diameter, and wherein an outer diameter of the occlusion element increases along the longitudinal axis to the maximum outer diameter.