Dual-Spiral Flow Diverter for Aneurysm Neck Sealing
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Solution Overview
Problem
Current methods for treating focal defects in artery walls, such as aneurysms, face challenges including navigation difficulties, intimal hyperplasia, and unintended occlusion of adjacent vessels, particularly with covered stents and flow-diverter stents, which can lead to adverse effects like neointimal hyperplasia and thrombosis.
Innovation Solution
A device comprising two barriers made from a single filament with memory shape, integrated with a pre-existing stent, strategically positioned to divert blood flow away from the aneurysm neck, minimizing contact with the parent vessel and avoiding high metal-to-artery ratios, thus reducing the risk of intimal hyperplasia and occlusion, while allowing for precise targeting and minimization of adverse effects on healthy vessel segments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If covered stents are used to treat aneurysms, then the aneurysm neck is effectively sealed, but intimal hyperplasia and thrombosis occur due to high metal-to-artery ratio
Solution Approach 1:
The device applies local quality by placing barriers only at specific locations (anterior and posterior walls of aneurysm neck) rather than covering the entire aneurysm circumference. This localized approach seals the aneurysm effectively while minimizing the metal-to-artery ratio and reducing the risk of intimalhyperplasia in healthy vessel segments.
Solution Approach 2:
The device segments the barrier function into two separate barriers positioned at specific locations around the aneurysm neck rather than using a single continuous covered stent. This segmentation allows effective aneurysm sealing while reducing overall metal contact with the arterial wall, thereby minimizing intimalhyperplasia.
2Reliability
If flow-diverter stents are used to treat aneurysms, then blood flow is diverted away from the aneurysm, but adjacent vessels may be unintentionally occluded
Solution Approach 1:
The barriers are designed with local quality by positioning them specifically at the anterior and posterior walls of the aneurysm neck. This localized placement diverts blood flow away from the aneurysm while preserving flow to adjacent vessels and branches, avoiding unintended occlusion.
3Measurement precision
If barriers are integrated onto pre-implanted stent, then precise positioning at focal defect is achieved, but device complexity increases
Solution Approach 1:
The device merges the barriers with the pre-implanted stent by integrating them onto the stent's radial elements. This combination allows precise positioning at the focal defect (aneurysm neck) while utilizing the existing stent structure, thereby managing device complexity through integration rather than adding completely separate components.
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 isolates the aneurysm neck from blood flow, promoting healing and reducing the risk of rupture, while maintaining the integrity of the parent vessel and avoiding complications like neointimal hyperplasia and thrombosis, thereby enhancing patient outcomes with precise and targeted treatment.
Implementation Method 1
The device is assembled from a single filament with a memory shape. This memory shape allows it to return to a predetermined configuration even after deformation, ensuring stability and functionality.
Implementation Method 2
The device comprises two spirals joined by an intermediate spring. These components likely serve multiple purposes, such as enhancing flexibility, adapting to vessel contours, and maintaining structural integrity.
Data Source
AI summary
The present invention consists of a flow diverter device deployed in the aneurysm neck to be used during an endovascular intervention. The device consists of a single filament that forms two spirals: the distal spiral (on the aneurysmal side) and the proximal spiral (on the vascular face of the stent). These spirals are continuous with a central spring that connects them. The spring passes through a predefined cell of a previously implanted stent. The distal and proximal barriers act as flow diverters. They cover a specific group of stent cells in front of the aneurysm neck. The intermediate spring traverses a stent cell, preventing movement. The two barriers, along with the connecting spring, play a crucial role in blocking any dislodgment after deployment. This invention combines precise positioning, flow diversion, and stability to address aneurysms effectively, avoiding direct manipulation of the lesion and respecting the parent vessel.