Aneurysm Occlusive Mesh Shaping for Rapid Thrombus Sealing
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Solution Overview
Problem
Conventional treatments for intracranial aneurysms, such as using platinum coils or flow diverters, face challenges with long-term recanalization and delayed thrombus formation, especially for aneurysms with wide necks or large volumes, and require antiplatelet therapy that may exacerbate hemorrhaging.
Innovation Solution
A method for manufacturing an occlusive device involving a tubular mesh that is shaped and heat-treated over a forming member to create a dual-layer sidewall, which is then deployed within an aneurysm to form a stable seal and is reinforced by an embolic element to transform into a second expanded state, providing immediate thrombus formation and structural support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If platinum coils are used to treat intracranial aneurysms, then the aneurysm interior volume is filled and thrombus formation is induced, but long-term recanalization occurs especially for aneurysms with wide necks and large interior volumes
Solution Approach 1:
The device divides the aneurysm treatment into two functional segments: an occlusive member that fills the aneurysm interior volume and an embolic element that is delivered through the occlusive member to promote thrombus formation. This segmentation allows each component to perform its specific function optimally, with the occlusive member providing immediate structural support and the embolic element inducing rapid thrombus formation to prevent recanalization.
Solution Approach 2:
The embolic element is nested within the occlusive member during delivery. The occlusive member is first deployed to fill the aneurysm interior volume, then the embolic element is delivered through the occlusive member's interior volume. This nested configuration allows both elements to be delivered through a single catheter system while maintaining their distinct functions, with the embolic element positioned exactly where thrombus formation is most critical.
2Reliability
If flow diverters are deployed to cause blood to preferentially flow along the main channel, then aneurysmal thrombus formation is promoted, but it takes weeks or months for full effect and antiplatelet therapy is required
Solution Approach 1:
The occlusive member is deployed first to immediately fill the aneurysm interior volume and provide structural support, creating a preliminary barrier that prevents blood flow into the aneurysm. This preliminary action eliminates the need for weeks or months of waiting for thrombus formation, as the occlusive member provides immediate occlusion. The embolic element is then delivered to reinforce this preliminary barrier and promote rapid thrombus formation.
Solution Approach 2:
The invention extracts the need for antiplatelet therapy by using an embolic element that actively promotes thrombus formation within the aneurysm. Instead of relying on flow diversion that requires antiplatelet therapy to prevent thrombus in the main channel, the embolic element is delivered directly into the aneurysm to induce localized thrombus formation, eliminating the contradiction between promoting thrombus in the aneurysm and preventing thrombus in the main channel.
3Reliability
If flow diverters are used to treat aneurysms, then thrombus formation in the aneurysm is promoted, but antiplatelet therapy may exacerbate intracranial hemorrhaging if re-rupture occurs
Solution Approach 1:
The occlusive member serves as an intermediary barrier between the blood flow and the aneurysm interior volume. By physically blocking blood flow into the aneurysm, the occlusive member eliminates the need for antiplatelet therapy to prevent thrombus formation in the main channel. The embolic element delivered through the occlusive member further reinforces this barrier and promotes localized thrombus formation within the aneurysm, providing dual protection without the hemorrhaging risk associated with antiplatelet therapy.
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 blood flow, promotes rapid thrombus formation, and provides immediate structural support, reducing the risk of aneurysm rupture and re-rupture, while avoiding the need for antiplatelet therapy.
Implementation Method 1
heat-treated over a forming member to create a dual-layer sidewall
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.