Biodegradable Stent Anti-Migration Barbs
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Solution Overview
Problem
Current stents, particularly those used in biliary and pancreatic placements, face issues with migration and require frequent replacement, leading to increased procedural costs and risks for patients with comorbidities, as they are not biodegradable and lack controlled degradation profiles.
Innovation Solution
A biodegradable stent with a double-channel helical twist design and anti-migration devices, composed of bioabsorbable polymers like PEG and p-dioxanone, which provides controlled fluid flow and remains in place for an intended period, eliminating the need for sequential replacements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If conventional non-biodegradable stents are used, then stent durability is improved, but stent migration occurs requiring frequent replacements
Solution Approach 1:
The patent changes the material parameter from non-biodegradable to biodegradable polymers with controlled degradation rates, and modifies the structural parameter by adding anti-migration devices with barbs that mechanically anchor the stent. This resolves the contradiction by ensuring the stent remains reliably positioned through both material integration with tissue and mechanical anchoring, while maintaining durability through controlled biodegradation that matches tissue healing timelines.
Solution Approach 2:
The patent employs composite material strategy by combining biodegradable polymer materials with anti-migration devices featuring barbed structures. The biodegradable stent body material (such as poly-L-lactide or poly-D,L-lactide) works in conjunction with the mechanical anti-migration components to simultaneously achieve durability through controlled degradation and position stability through physical anchoring in the vessel wall.
2Reliability
If sequential plastic stent placements are performed, then duct drainage is improved, but procedural costs and patient risks increase
Solution Approach 1:
The patent applies the disposable principle by using a single biodegradable stent that eliminates the need for sequential permanent stent placements. The stent is designed to perform its drainage function reliably during the critical healing period and then naturally degrade, replacing the paradigm of multiple permanent stents with one temporary biodegradable stent, thereby reducing procedural time, costs, and patient risks associated with repeated interventions.
Solution Approach 2:
The patent changes the temporal parameter from requiring multiple stent placements over 6-12 months to a single stent placement with controlled degradation over a specific timeframe. This parameter change in treatment duration and frequency, combined with the biodegradable material property, resolves the contradiction by providing reliable duct drainage during the needed period while eliminating the need for repeated procedures.
3Reliability
If stent migration is prevented through mechanical anchoring, then position stability is improved, but stent design complexity increases
Solution Approach 1:
The patent applies segmentation by dividing the stent into distinct functional segments: the biodegradable stent body for drainage and the separate anti-migration devices with barbed elements for anchoring. This segmentation allows each component to perform its specific function optimally while keeping the overall design relatively simple - the barbed elements are added as distinct features rather than complicating the entire stent structure.
Solution Approach 2:
The patent inverts the conventional approach by adding anti-migration devices to the stent rather than making the stent itself complex. Instead of creating a highly complex self-anchoring stent structure, the invention adds separate barbed elements that provide anchoring function, thereby achieving position stability with minimal increase in overall device complexity.
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 stent ensures controlled degradation, reduces migration, and enhances fluid flow and crush resistance, minimizing clinical costs and complications by eliminating the need for frequent replacements.
Implementation Method 1
The stent body typically has a central lumen that allows blood or other body fluid to flow through the stent. A common problem with the current stents is that they routinely migrate and clog... there is a need for a biodegradable stent device... composed of a biodegradable material... controlled degradation
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 has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. The stent also has an anti-migration device used for immobilization of the stent at the target site.