Bioabsorbable Helical Stent for Flow and Migration Resistance
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Solution Overview
Problem
Current stents, particularly those used in biliary and pancreatic applications, face issues with migration and clogging, requiring frequent replacements and increasing the risk of complications for patients with comorbidities, especially in chronic pancreatitis where fibrotic strictures necessitate prolonged stent placement.
Innovation Solution
A biodegradable stent with a double-channel helical twist design, composed of bioabsorbable polymers, is developed to provide improved fluid communication and support, featuring spiral channels on its exterior surface to enhance flow and reduce migration, and a central lumen for guide wire passage, allowing for bile drainage and potential drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stents are used in biliary and pancreatic applications, then the stent structure is simple and easy to manufacture, but the stent migrates and clogs requiring frequent replacements
Solution Approach 1:
The stent is divided into multiple segments including a central lumen and multiple external channels (first and second channels) that are segmented along the longitudinal axis. This segmentation allows fluid to flow through multiple separate pathways, reducing the likelihood of complete occlusion and improving reliability without requiring a completely new stent design
Solution Approach 2:
The invention transitions from a traditional single-lumen stent to a multi-channel structure by adding external channels on the stent surface. This dimensional expansion from one central pathway to multiple distributed pathways improves fluid flow reliability and prevents migration-related complications while maintaining a manageable structural complexity
2Reliability
If multiple plastic stents are placed sequentially for fibrotic duct strictures, then the obstruction is addressed, but the procedures are expensive and increase patient risks
Solution Approach 1:
The invention merges the functions of multiple sequential stent placements into a single multi-channel stent device. The first and second external channels work together to provide continuous fluid flow and pressure equalization, achieving the therapeutic effect of multiple stents while eliminating the need for repeated procedures and reducing patient exposure to procedural risks
Solution Approach 2:
The multi-channel design ensures continuous fluid flow through multiple pathways simultaneously, maintaining constant pressure equalization across the stricture. This continuous action through parallel channels provides sustained therapeutic effect without the interruptions and gaps inherent in sequential stent replacement procedures
3Productivity
If traditional stents are used, then the device is simple, but fluid flow rates are insufficient and migration occurs
Solution Approach 1:
The stent incorporates localized features including varying channel depths, widths, and orientations at different positions along the stent length. The first and second external channels have different configurations optimized for specific flow requirements, allowing high fluid flow rates through locally optimized pathways without requiring complete redesign of the entire stent structure
Solution Approach 2:
The invention utilizes hydraulic principles by creating multiple fluid communication pathways that leverage pressure gradients and fluid dynamics. The external channels are designed to optimize fluid flow rates through appropriate cross-sectional areas, lengths, and orientations, achieving high productivity through hydraulic efficiency rather than increased device complexity
Data Source
AI summary
A stent is disclosed that has an elongated body composed of a bioabsorbable polymer having a proximal end, a distal end, two open spiral channels formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end. The stent also has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. A method for using the stent and a kit containing the stent are also disclosed.