Bio-Absorbable Wire Stent Assembly Without High-Heat Joining
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Solution Overview
Problem
Traditional bioresorbable medical devices, such as stents, face challenges in maintaining mechanical and resorption properties during assembly and implantation due to adverse effects from manufacturing processes, particularly high-heat methods that can alter the properties of bio-metals like magnesium, leading to potential device failure and compromised durability.
Innovation Solution
The use of bio-absorbable metals like magnesium and its alloys, secured with joining cuffs that maintain the structural integrity and durability of the stents without requiring high-heat processes, and the incorporation of radiopaque markers for improved positioning and visualization during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If high-heat manufacturing processes are used to assemble bio-metal implants, then assembly can be achieved, but the mechanical and resorption properties of the bio-metals are altered
Solution Approach 1:
The patent replaces thermal joining processes with mechanical joining methods. Specifically, it uses friction stir welding (a mechanical process involving a rotating tool that mixes metals at the interface) and diffusion bonding (a solid-state joining process) to connect bio-metal components without exposing them to high temperatures that would alter their mechanical and resorption properties.
Solution Approach 2:
The patent changes the joining parameters from high-temperature thermal processes to low-temperature mechanical processes. By using friction stir welding and diffusion bonding at temperatures below the recrystallization temperature of the bio-metals, the patent maintains the material properties while achieving reliable component assembly.
2Ease of manufacture
If high-heat manufacturing processes are used to assemble bio-metal implants, then assembly can be achieved, but the resorption characteristics are compromised
Solution Approach 1:
The patent replaces thermal joining processes with mechanical joining methods. Specifically, it uses friction stir welding (a mechanical process involving a rotating tool that mixes metals at the interface) and diffusion bonding (a solid-state joining process) to connect bio-metal components without exposing them to high temperatures that would alter their mechanical and resorption properties.
Solution Approach 2:
The patent changes the joining parameters from high-temperature thermal processes to low-temperature mechanical processes. By using friction stir welding and diffusion bonding at temperatures below the recrystallization temperature of the bio-metals, the patent maintains the material properties while achieving reliable component assembly.
3Reliability
If mechanical joining methods are used to secure wires, then the durability and physical properties are maintained, but the assembly complexity increases
Solution Approach 1:
The patent segments the assembly process into distinct stages: wire formation, mechanical joining using friction stir welding or diffusion bonding, and final implant assembly. This segmentation allows each process to be optimized independently and facilitates modular manufacturing, reducing overall complexity despite the sophisticated joining methods used.
Data Source
AI summary
Modularizable implants and stents made with bio-absorbable metal wire alloys (‘bio-metals’, e.g. magnesium and alloys), and methods for making such implants and stents. The stents or implants may include one or more wire-formed rings or comprise inter-connected cells that form nets that may serve as modules that are assembled mechanically into stents, without the need for certain manufacturing processes that may affect the durability and physical properties thereof. The wires may be formed into rings mechanically and held in place using joining cuffs, and/or adjacent wires may be secured to one other mechanically using joining cuffs to form nets which can be used as implants or formed into stents. The stents can include radiopaque portions, e.g. associated with one or more joining cuffs, to aid in the positioning and evaluation of stents in the body by serving as visual indicators of alignment and expansion that can be detected using X-rays.