Biodegradable Flow Diverter Mesh With Tunable Pores for Aneurysm Occlusion
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Solution Overview
Problem
Current braided flow-diverter devices (FDDs) for aneurysm treatment are limited by their metallic, non-biodegradable nature, lack of controllable design parameters, and inability to regulate blood flow effectively, leading to complications such as late thrombosis, rupture, and incomplete occlusion.
Innovation Solution
A non-braided, biodegradable flow diverter device (FDD) fabricated using fused deposition model (FDM) 3D printing technology, with adjustable parameters controlled by G-codes, producing continuous microfiber with precise surface quality and pore shapes, and incorporating biodegradable materials like PCL for controlled blood flow regulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If mesh/braided metallic FDDs are used for aneurysm treatment, then structural support and immediate hemodynamic effect are improved, but long-term inflammation, lack of biodegradability, and limited design flexibility worsen
Solution Approach 1:
The patent changes the material parameter from permanent metallic alloys to biodegradable polymers (PLA, PLGA, PCL), transforming the device from non-biodegradable to biodegradable while maintaining structural support through controlled degradation rates that match tissue healing timelines
Solution Approach 2:
The patent uses composite biodegradable polymer materials with tuned mechanical and degradation properties to achieve both immediate structural support and long-term biodegradability, combining the benefits of metallic strength with the advantages of polymer biocompatibility
2Ease of manufacture
If braided FDD design is used, then manufacturing simplicity is improved, but design parameter control and blood flow regulation capability worsen
Solution Approach 1:
The patent applies local quality by varying pore size, shape, and distribution in different regions of the FDD to regulate blood flow specifically at the aneurysm neck while maintaining appropriate flow in the parent vessel, achieving localized hemodynamic control that braided designs cannot provide
Solution Approach 2:
The patent introduces dynamic adaptability through controllable design parameters including pore geometry, strut thickness, and pattern density that can be adjusted based on specific aneurysm characteristics, allowing the device to adapt to different clinical scenarios rather than being limited to fixed braided patterns
3Strength
If metallic alloys are used for FDD fabrication, then mechanical strength and radiopacity are improved, but biodegradability and inflammatory response worsen
Solution Approach 1:
The patent changes the material composition parameter from metallic alloys to biodegradable polymers, fundamentally altering the material's interaction with biological systems to reduce chronic inflammation while maintaining sufficient mechanical strength through optimized polymer formulation and device architecture
Solution Approach 2:
The patent employs biodegradable materials that temporarily provide structural support during the critical healing period then naturally degrade and are absorbed by the body, eliminating the need for permanent foreign bodies and associated long-term inflammatory responses
4Adaptability or versatility
If non-braided FDD design is implemented, then design flexibility and blood flow regulation are improved, but manufacturing complexity increases
Solution Approach 1:
The patent replaces complex mechanical braiding processes with additive manufacturing (3D printing) technology, enabling precise control over pore geometry and strut configuration while simplifying the manufacturing process through digital modeling and automated fabrication
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 biodegradable FDDs provide improved clinical outcomes by reducing long-term inflammation, allowing re-intervention, and effectively regulating blood flow, minimizing complications like distant embolism and thrombosis, while being compatible with medical imaging and diagnostics.
Implementation Method 1
The present invention provides a fabrication method that exploits fused deposition model (FDM) based 3D printing technology
Implementation Method 2
All of the forgoing FDDs are mesh/braided designs; none are bioresorbable
Data Source
AI summary
A biodegradable flow diverting device (BFDD) that will regulate blood flow into an aneurysmal sac, act as a scaffold for endothelization at the neck of an aneurysm, and degrade after successful dissolution of aneurysm and remodeling of blood vessel. This BFDD and associated fabrication method have the following features: (1) This is a non-braided FDD. The pore shapes, sizes, architectures (especially at the inlet and outlet of the pores), pore densities and porosities can be controlled for the optimum performance depending on the blood vessel and aneurysmal morphologies from patient MRI images, (2) BFDD is developed on a rotary arm with programmable variable speed and diameter in conjunction with a micromotion stage (3) Fabrication system can take any material including blended/composite biomaterials by adjusting temperature of the electro-melt extruder/needle and (4) Fabrication system is compatible with CAM (computer aided manufacturing) software and able to operate based on the adapted G-code.