Flexible Embolization Scaffold for Aneurysm Conformity
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Solution Overview
Problem
Existing embolization devices for aneurysms are often rigid, making them difficult to deliver to aneurysms with complex anatomy, require custom microcatheters, and pose a higher risk of rupture, especially in broad-based or ruptured aneurysms.
Innovation Solution
A low-profile, flexible embolization scaffold device with integrated embolization coils that can conform to various aneurysm shapes, allowing for single-step obliteration and minimizing transmural wall pressure, and can be re-sheathed or re-deployed if initially misplaced, without the need for dual-antiplatelet therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If rigid embolization devices are used, then structural strength is improved, but deliverability to complex aneurysms and compliance with vessel anatomy deteriorates
Solution Approach 1:
The embolization device incorporates a dynamic structure that transitions from a compressed delivery configuration to an expanded functional configuration. The device includes a delivery catheter that maintains the device in a low-profile compressed state for navigation, then allows expansion at the target site to provide structural support and embolization functionality.
Solution Approach 2:
The embolization device is nested within a delivery catheter during delivery, allowing the device to be compressed into a small profile for navigation through complex vasculature. Once positioned at the aneurysm site, the device is deployed from the catheter and expanded to its functional configuration, providing both deliverability and structural strength.
2Ease of operation
If custom or large-bore microcatheters are used to deliver rigid devices, then device delivery is achieved, but procedural complexity and patient risk increase
Solution Approach 1:
The device is designed to be delivered through a universal delivery catheter system that does not require custom or large-bore microcatheters. The device's compressed configuration allows it to navigate through standard catheter sizes, reducing procedural complexity and eliminating the need for specialized catheter fabrication.
3Reliability
If rigid embolization devices are deployed in ruptured aneurysms, then embolization can be achieved, but risk of aneurysm rupture increases
Solution Approach 1:
The device is designed to minimize transmural wall pressure during deployment by expanding gradually and conforming to the aneurysm geometry. The compliant structure distributes pressure evenly across the aneurysm wall, preventing focal stress concentrations that could trigger rupture in compromised aneurysms.
Solution Approach 2:
The embolization device incorporates flexible, compliant materials that allow the structure to conform to the aneurysm wall and distribute mechanical stress evenly. This flexibility reduces the risk of causing wall rupture during deployment while maintaining embolization effectiveness.
4Productivity
If integrated embolization coils are used with scaffold, then single-step treatment is achieved, but device complexity increases
Solution Approach 1:
The device merges the scaffold structure with integrated embolization coils into a single unified device. The coils are incorporated into the scaffold framework, allowing simultaneous deployment of both the supportive scaffold and the embolizing coils in a single step, improving treatment efficiency while managing complexity through integrated design.
Data Source
AI summary
An embolization scaffold device. The scaffold has a base having a central longitudinal axis extending therethrough and a plurality of expandable struts extending from the base. Each of the struts has a proximal portion extending from the base and substantially aligned with the central longitudinal axis, an intermediate arcuate portion radially extending away from the central longitudinal axis, and a distal portion curving back towards the central longitudinal axis.