Occlusive Devices With Thrombogenic Inserts for Wide-Neck Aneurysms
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Solution Overview
Problem
Existing treatments for intracranial aneurysms, such as balloon- and stent-assisted coiling and flow diverters, face challenges including increased procedural complexity, risk of clot formation, and hemorrhagic complications, particularly for wide-necked and ruptured aneurysms, limiting their effectiveness and safety.
Innovation Solution
An occlusive device with an expandable mesh and a thrombogenic insert is deployed within the aneurysm to promote thrombosis, featuring structures like pores, texturing, or active agents to enhance clot formation, while the mesh covers the aneurysm neck and supports endothelialization, reducing the need for dual antiplatelet therapy and minimizing complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If balloon- or stent-assisted coiling is used to treat wide-necked aneurysms, then coil migration is prevented and occlusion rate is improved, but procedural complexity and risk of clot formation increase
Solution Approach 1:
The patent extracts the neck-bridging function from the parent vessel and relocates it to an insert device positioned within the aneurysm sac. This eliminates the need for balloon or stent assistance in the parent vessel, reducing procedural complexity while maintaining coil retention capability.
Solution Approach 2:
The insert acts as an intermediary device that provides neck-bridging support indirectly from within the aneurysm sac, rather than directly from the parent vessel. This intermediary approach reduces the invasive nature of the procedure and lowers the risk of clot formation in the parent vessel.
2Reliability
If flow diverters are positioned in the parent vessel, then aneurysm thrombosis is promoted, but dual antiplatelet therapy is required increasing hemorrhagic risk
Solution Approach 1:
The patent extracts the thrombogenic function from the parent vessel environment and relocates it to an insert device positioned within the aneurysm sac. This eliminates the need for flow diverters in the parent vessel, allowing thrombosis promotion without requiring dual antiplatelet therapy.
Solution Approach 2:
The insert is designed with localized thrombogenic features (porous structure, texturing, or active agents) that promote clot formation specifically within the aneurysm sac while leaving the parent vessel endothelium intact, avoiding the systemic anticoagulation requirements of flow diverters.
3Reliability
If coils are packed into the aneurysm sac, then blood flow into the aneurysm is disrupted, but coil segments may protrude through the neck causing complications
Solution Approach 1:
The insert serves as an intermediary barrier within the aneurysm sac that provides structural support at the neck region. This intermediary structure prevents coil migration through the neck while allowing effective blood flow disruption within the aneurysm sac.
Solution Approach 2:
The insert is nested within the aneurysm sac to provide internal support structure. This nested configuration allows the insert to constrain coils prevent neck protrusion while maintaining the therapeutic blood flow disruption within the aneurysm.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively occludes aneurysms by promoting thrombosis and endothelialization, enhancing healing and reducing recanalization risk, thus improving treatment safety and efficacy for wide-necked and ruptured aneurysms without increasing hemorrhagic complications.
Implementation Method 1
the insert can be configured to promote thrombosis when the occlusive device is deployed within the aneurysm
Implementation Method 2
the mesh covers the aneurysm neck and supports endothelialization
Data Source
AI summary
Devices for treating vascular defects and associated systems and methods are disclosed herein. In some embodiments, an occlusive device for treating an aneurysm includes an expandable mesh configured to span a neck of the aneurysm. The expandable mesh can include an upper wall and a lower wall. The occlusive device can also include an insert positioned within the expandable mesh between the upper and lower walls. The insert can have an inner surface and an outer surface. The inner surface of the insert can face the upper wall of the expandable mesh, and the outer surface of the insert can face the lower wall of the expandable mesh. The insert can be configured to promote thrombosis when the occlusive device is deployed within the aneurysm.