Aneurysm Occlusive Mesh for Immediate Neck Sealing
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Solution Overview
Problem
Current treatments for intracranial aneurysms, such as platinum coil and flow diverter methods, face challenges with long-term recanalization and the need for antiplatelet therapy, which can be risky, especially after aneurysm rupture, highlighting the need for innovative solutions to promptly and effectively treat and prevent re-rupture.
Innovation Solution
A method for creating an occlusive device involving a tubular mesh that is shaped and configured to expand within an aneurysm, using a forming member and embolic elements to form a stable seal at the aneurysm neck, preventing blood flow and promoting endothelial growth, while being designed to prevent blood flow through its porosity and using resilient and superelastic materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If flow diverter is deployed in intracranial blood vessel, then blood flow is redirected away from aneurysm, but weeks to months are required for thrombus formation and endothelial coverage
Solution Approach 1:
The occlusive device is pre-configured with an optimal combination of porosity values before deployment. The first porosity in the neck portion and second porosity in the body portion are predetermined to achieve immediate effective occlusion upon deployment, eliminating the prolonged waiting period required for thrombus formation that characterizes flow diverter treatment
2Reliability
If flow diverter is used to treat aneurysm, then aneurysm occlusion is achieved, but antiplatelet therapy is required which increases re-rupture risk after initial rupture
Solution Approach 1:
The occlusive device is designed as a single-use, disposable implant that provides immediate and permanent occlusion of the aneurysm. The device's structure with optimized porosity values ensures complete blood flow cessation upon deployment, eliminating the need for prolonged antiplatelet therapy and thereby reducing the risk of re-rupture associated with long-term medication use
3Reliability
If tubular mesh is expanded within aneurysm, then stable seal is formed at aneurysm neck, but device complexity increases with forming members and embolic elements
Solution Approach 1:
The occlusive device is nested within a forming assembly during deployment. The forming assembly includes a forming member with a cavity that receives the compressed occlusive device, and the assembly is delivered through a catheter system. Upon deployment, the occlusive device expands from its compressed state to its functional state with the predetermined porosity configuration, achieving stable seal without requiring complex external manipulation devices
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 occlusive device effectively prevents aneurysm rupture by forming a stable seal and promoting endothelial growth, reducing the risk of recanalization and eliminating the need for antiplatelet therapy, thus providing a safer and more effective treatment for intracranial aneurysms.
Implementation Method 1
using resilient and superelastic materials
Implementation Method 2
using resilient and superelastic materials
Data Source
AI summary
Occlusive devices and associated methods of manufacturing are disclosed herein. Manufacturing an occlusive device can include conforming a mesh to a forming assembly and setting a shape of the mesh based on the forming assembly. In some embodiments, the forming assembly comprises multiple forming members, a mandrel, and/or one or more coupling elements. The method may include everting the mesh over the forming assembly such that the mesh encloses an open volume with a shape based, at least in part, on the shape of the forming assembly. According to some embodiments, setting a shape of the mesh comprises heat-treating the mesh and forming assembly.