Spherical Vascular Remodeling Device for Aneurysm Coil Containment
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Solution Overview
Problem
Current vascular remodeling devices struggle to effectively prevent herniation of embolization coils and thrombi at neurovascular bifurcations with aneurysms, especially those with neck ratios greater than 2:1 or less than 4 mm, due to difficulties in shaping devices to preserve blood flow and inhibit herniation into parent vessels.
Innovation Solution
A generally spherical vascular remodeling device is deployed at the junction of afferent and efferent vessels, comprising a plurality of polymer filaments that lock into place across the arterial ostia and neck of the aneurysm, inhibiting herniation while allowing perfusion of fluid to efferent vessels, and can be made from bioabsorbable materials for temporary support during aneurysm thrombosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tubular remodeling devices are used to inhibit herniation of coils, then coil containment is improved, but device adaptability to bifurcation geometries deteriorates
Solution Approach 1:
The patent employs a spherical remodeling device instead of traditional tubular shapes. The spherical geometry naturally adapts to the three-dimensional bifurcation junction, allowing the device to conform to complex angular relationships between vessels while maintaining effective coil containment across multiple directions simultaneously.
Solution Approach 2:
The invention transitions from two-dimensional planar stent designs to a three-dimensional spherical structure. This dimensional change enables the device to address herniation risks in multiple spatial directions (anterior, posterior, left, right) concurrently, providing comprehensive protection at the bifurcation junction that tubular devices cannot achieve.
2Ease of manufacture
If the neck ratio is greater than 2 to 1 or neck is less than 4 mm, then embolization coils can be used alone, but coil herniation risk increases
Solution Approach 1:
The spherical remodeling device serves as an intermediary structure between the embolization coils and the aneurysm neck. It provides a scaffolding framework that guides and constrains the coils within the aneurysm sac, preventing herniation through the neck while maintaining the simplicity of coil-based treatment approach.
Solution Approach 2:
The invention changes the geometric parameters of the treatment approach by introducing a spherical structure with specific diameter ratios (device diameter to neck diameter). This parameter change allows effective coil containment even in challenging anatomical configurations where traditional approaches fail.
3Ease of operation
If tubular remodeling devices are shaped to preserve blood flow, then blood flow preservation is improved, but herniation inhibition capability deteriorates
Solution Approach 1:
The spherical device is segmented into multiple functional zones: a proximal portion for anchoring in the afferent vessel, a distal portion for anchoring in efferent vessels, and an equatorial region for coil containment. This segmentation allows each zone to be optimized for its specific function while working together to preserve blood flow and prevent herniation simultaneously.
Solution Approach 2:
Different regions of the spherical device have different structural properties tailored to local requirements. The proximal and distal poles have denser structures for anchoring and flow preservation, while the equatorial region has appropriate porosity for coil containment, creating local quality variations that address multiple objectives.
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 prevents herniation of embolization coils and thrombi, maintains blood flow, and can be bioabsorbed when no longer needed, reducing the risk of complications and improving treatment outcomes for complex aneurysms.
Implementation Method 1
The polymer filaments may comprise bioabsorbable polymers (e.g., polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), poly-epsilon-caprolactone, and/or naturally-derived bioabsorbable polymers)
Data Source
AI summary
A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of polymer filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of polymer loops forming a generally spherical shape.