Over-the-wire Aneurysm Exclusion Device for Bifurcation Treatment
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Solution Overview
Problem
Current treatments for neurovascular aneurysms, such as coiling and stent-assisted coiling, face limitations including recanalization, mass effect on surrounding tissue, and risk of clot formation, as they do not effectively restrict blood flow to the aneurysm neck or allow for aneurysm shrinkage, and are not suitable for bifurcations or side branch arteries.
Innovation Solution
An over-the-wire exclusion device with a thin-walled, ductile shell and two-port design that can be delivered and deployed via a guidewire, allowing for collapse and detachment without additional hardware, effectively sealing the aneurysm neck and reducing blood flow to trigger thrombus formation, while maintaining arterial patency and allowing for therapeutic interventions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If coiling is used to treat aneurysms, then blood flow into the aneurysm is reduced, but recanalization occurs and coils may prolapse into the parent vessel
Solution Approach 1:
The patent employs a flexible membrane or shell structure that conforms to the aneurysm geometry and seals the aneurysm neck. This flexible barrier prevents coil prolapse into the parent vessel while maintaining aneurysm exclusion, directly addressing the harmful effects of coil migration and recanalization observed in traditional coiling.
Solution Approach 2:
The device divides the treatment function into separate components: an exclusion element that seals the aneurysm neck and a support structure that prevents recanalization. This segmentation allows the exclusion membrane to focus on sealing while the support framework maintains patency and prevents re-opening of the aneurysm.
2Stability of the object's composition
If stent-assisted coiling is used, then coil stability is improved, but mass effect on surrounding tissue increases and clot formation risk increases
Solution Approach 1:
The patent extracts the stabilization function from the stent structure itself and transfers it to a separate support framework or delivery system. This allows the exclusion membrane to be thinner and less invasive, reducing mass effect on surrounding tissue while maintaining coil stability through the dedicated support structure.
Solution Approach 2:
The device applies support and stabilization locally at the aneurysm neck rather than through a long stent extending into the parent vessel. This localized approach reduces the overall mass effect on surrounding healthy tissue while providing sufficient support to prevent coil migration and recanalization.
3Reliability
If current treatments are used, then aneurysm flow restriction is achieved, but treatment at bifurcations and side branch arteries is not suitable
Solution Approach 1:
The exclusion device is designed with dynamic characteristics that allow it to adapt to different anatomical configurations. The flexible membrane can conform to various aneurysm shapes and locations, including bifurcations and side branch arteries, while maintaining effective flow restriction through the aneurysm neck.
Solution Approach 2:
The device is designed as a universal solution that can treat aneurysms at various locations including bifurcations and side branch arteries. The flexible exclusion membrane and adaptable support structure allow single device design to serve multiple anatomical configurations, eliminating the need for location-specific treatment limitations.
4Reliability
If craniotomy is performed for aneurysm clipping, then complete aneurysm obliteration is achieved, but brain injury risk and neurological defects increase
Solution Approach 1:
The patent introduces an endovascular exclusion device as an intermediary treatment that achieves aneurysm sealing without requiring open craniotomy. The device is delivered through the vascular system and deployed within the aneurysm, providing complete obliteration of aneurysm flow while avoiding the traumatic effects of skull opening and brain retraction.
Solution Approach 2:
The invention replaces the mechanical clipping system requiring craniotomy with an endovascular deployment system. The exclusion device is delivered catheter-based and activated remotely, substituting the invasive mechanical clipping procedure with a less invasive endovascular mechanism that achieves the same therapeutic goal without brain injury risks.
Data Source
AI summary
A modification to allow delivery of a two port medical flow restrictor over a guidewire, and a means to mechanically collapse the new device. A thin walled, foil-like shell, is compacted for delivery. The invention includes the device, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Mechanical force collapses both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.