Biodegradable Embolic Bead Production for Controlled Particle Sizes
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Solution Overview
Problem
Existing embolic materials face challenges such as non-biodegradability, difficulty in achieving specific sizes, potential vessel damage, and complexity in use due to varying vessel diameters and lesion sizes, along with production inefficiencies in achieving desired particle diameters.
Innovation Solution
A method involving the mixing of biodegradable polymers and surfactants at room temperature to produce embolic materials with controlled particle sizes, followed by washing, drying, crosslinking, and coating, which results in spherical beads with a curved surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a particulate type embolic material is used, then the embolization procedure can be performed, but the material does not biodegrade in blood vessels and may cause inflammatory response
Solution Approach 1:
The patent changes the material composition parameter by using biodegradable polymers (PLA, PLGA, PCL) instead of non-biodegradable materials. This parameter change enables the embolic material to degrade into harmless byproducts (carbon dioxide and water) after fulfilling its embolization function, thereby eliminating the inflammatory response while maintaining embolization effectiveness.
2Reliability
If a particulate type embolic material is used, then the procedure can be performed, but the material has poor elasticity or flexibility requiring consideration of vessel diameter and lesion characteristics
Solution Approach 1:
The patent applies the dynamics principle by designing the embolic material with shape memory properties that allow it to change form dynamically. The material is injected in a compressed or amorphous state for easy delivery through catheters, then transforms into a predetermined spherical shape with controlled porosity at the target site, adapting to different vessel diameters and lesion characteristics without requiring operator judgment about material selection.
Solution Approach 2:
The patent applies preliminary action by pre-setting the final shape and porosity characteristics of the embolic material during the manufacturing process. The spherical shape with controlled porosity (40-60%) is established before injection, ensuring consistent expansion and embolization effect across different application scenarios, thereby eliminating the need for operators to consider various vessel and lesion parameters when selecting material type.
3Reliability
If a membrane type embolic material is used, then the procedure can be performed, but the material needs to be cut to appropriate size during surgery and sharp cut edges may damage the inner wall of the blood vessel
Solution Approach 1:
The patent applies the spheroidality principle by forming the embolic material into a spherical shape with smooth curved surfaces. This eliminates sharp edges that could damage the vessel wall during injection or after deployment. The spherical geometry with controlled porosity (40-60%) ensures gentle interaction with the blood vessel interior while maintaining effective embolization through controlled blood flow occlusion.
4Reliability
If a coil-type embolic material is used, then the procedure can be performed, but the material has relatively high rigidity and sharpness that may cause emergency situations such as aneurysmal rupture
Solution Approach 1:
The patent changes the physical parameters of the embolic material by using biodegradable polymer compositions with controlled porosity (40-60%) instead of rigid metal coils. This parameter change reduces the rigidity and sharpness of the material, allowing it to conform to the blood vessel geometry without causing mechanical stress that could lead to aneurysmal rupture, while still achieving effective blood flow occlusion through embolization.
Solution Approach 2:
The patent applies the flexible shells principle by using biodegradable polymer materials that possess flexibility and conformability. The embolic material can deform and adapt to the contours of the blood vessel and aneurysm sac, distributing mechanical stress evenly rather than concentrating it at sharp edges or rigid structures, thereby eliminating the risk of aneurysmal rupture while maintaining embolization effectiveness.
5Ease of manufacture
If conventional water-oil or oil-water emulsion method is used for embolic material production, then the process can be performed, but it is not easy to produce beads having the size desired by the user and thus difficult to obtain beads having specific average particle diameter in high yield
Solution Approach 1:
The patent applies parameter changes by optimizing the emulsion process parameters including surfactant concentration (0.1-5 wt%), polymer concentration (1-10 wt%), solvent type and ratio, stirring speed (500-2000 rpm), and temperature control. These parameter adjustments enable precise control over bead formation, allowing consistent production of beads with specific average particle diameters (e.g., 100-250 μm) in high yield while maintaining production feasibility.
6Reliability
If coil-type embolic material is used, then the procedure can be performed, but the process of removing the coil injected into the body must be performed after the embolization effect has been manifested
Solution Approach 1:
The patent applies the discarding principle by using biodegradable polymer materials that automatically degrade and are eliminated from the body after fulfilling their embolization function. The material breaks down into harmless byproducts (carbon dioxide and water) through hydrolysis and enzymatic degradation, eliminating the need for a separate removal process and the associated time loss, while maintaining reliable embolization effectiveness during the required period.
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 method enables high-yield production of embolic materials with controlled sizes that self-expand in vessels, minimizing vessel damage and eliminating the need for size-specific selection, while being naturally biodegradable and reducing post-procedure removal requirements.
Implementation Method 1
a stirring step of mixing a biodegradable polymer solution and a surfactant solution at room temperature to obtain a stirred material
Implementation Method 2
a collection step of collecting beads from the stirred material; wherein in the stirring step, the surfactant solution contains multiple kinds of surfactants
Data Source
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AI summary
Disclosed herein is a method for producing an embolic material. The method for producing an embolic material includes a stirring step of mixing a biodegradable polymer solution and a surfactant solution at room temperature to obtain a stirred material, and a collection step of collecting beads from the stirred material. In the stirring step, the surfactant solution may contain multiple kinds of surfactants.