Stent Capped-Release Mechanism for Granulation Tissue Prevention
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Solution Overview
Problem
Current stents and catheters face issues with fibrin sheath and granulation tissue formation, leading to occlusions, complications such as sepsis, thrombosis, and infection, due to the delayed and non-localized release of anti-granulation agents, which are not effectively addressed by existing solutions.
Innovation Solution
A stent design with capped-release mechanisms that utilize bioabsorbable or biodegradable caps with controlled degradation rates for sudden and localized release of anti-granulation agents at specific zones, such as luminal, abluminal, and port openings, to prevent granulation tissue and fibrin sheath formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If drug-eluting stents with delayed release of agents are used, then the agent is released slowly over time, but the agent loses efficacy by the one-month mark when granulation tissue forms
Solution Approach 1:
The patent employs periodic action through a two-stage release mechanism: an initial burst release phase (first period) delivering high concentrations of anti-granulation agents immediately upon deployment, followed by a delayed sustained release phase (second period) that activates after granulation tissue begins to form. This periodic release pattern ensures the agent remains effective throughout the critical one-month period when granulation tissue formation occurs, rather than losing efficacy as with continuous slow-release mechanisms.
Solution Approach 2:
The patent applies preliminary action by pre-positioning the anti-granulation agents in a dormant state within the stent structure before deployment. The agents are prepared in advance to be released in a controlled burst at the precise moment when the stent is deployed, ensuring immediate therapeutic effect at the site of granulation tissue formation. This preliminary preparation allows the agent to be delivered at the optimal time and concentration to prevent granulation tissue, rather than relying on slow diffusion that causes efficacy loss.
2Speed
If global delivery of fast-acting agents is used, then immediate disruption of granulation tissue is achieved, but the release is not localized and loses efficacy as tissue build-up delays set in
Solution Approach 1:
The patent implements local quality by distributing multiple discrete agent reservoirs at specific strategic locations on the stent surface, particularly at port openings and zones prone to granulation tissue formation. Each reservoir is localized to deliver the anti-granulation agent precisely where needed, rather than global delivery that disperses the agent uniformly and loses effectiveness. This localized approach ensures high concentration of agent at critical sites while maintaining speed of release.
Solution Approach 2:
The patent applies segmentation by dividing the anti-granulation agent delivery system into multiple separate reservoirs distributed across the stent surface, each capable of independent burst release. This segmentation allows different regions of the stent to receive targeted agent delivery at the appropriate speed and concentration, preventing the loss of efficacy associated with non-localized global delivery while maintaining the immediate disruptive effect needed to prevent granulation tissue.
3Ease of operation
If self-expanding or migrating pulmonary stents are used, then stent deployment is facilitated, but motion-mediated trauma leads to higher incidence rates of granulation tissue formation
Solution Approach 1:
The patent applies preliminary anti-action by incorporating anti-granulation agents that are released in a controlled burst immediately upon stent deployment, before motion-mediated trauma can initiate granulation tissue formation. This preliminary therapeutic action counteracts the harmful effects of stent motion and expansion trauma by creating a protective chemical environment that prevents the inflammatory cascade leading to granulation tissue. The agent is positioned and prepared to act preemptively against the anticipated trauma from self-expansion or migration.
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 controlled and sudden release of anti-granulation agents effectively prevents granulation tissue and fibrin sheath recurrence, enhancing therapeutic efficacy and reducing complications like occlusions and inflammation, while minimizing adverse reactions.
Implementation Method 1
A stent design with capped-release mechanisms that utilize bioabsorbable or biodegradable caps with controlled degradation rates
Implementation Method 2
A stent design with capped-release mechanisms that utilize bioabsorbable or biodegradable caps with controlled degradation rates
Data Source
AI summary
Disclosed and claimed is any one of long-dwelling body lumen apparatus, such as a catheter or stent (c/s), said c/s comprising: at least one lumen fittingly disposed within a tubular member; a scaffold circumferentially disposed around at least one of an outer surface of at least the tubular member; said scaffold radially extending for at least a portion of the length of the at least tubular member. Furthermore, the scaffold comprised of any one of a pattern of interlocking struts with individual well-like reservoirs disposed; each reservoir having a depth sufficient enough to house at least a first agent of any one of a chemical moiety, each of the reservoirs capped to form an enclosure; and wherein a delayed degradation of said cap results in a sudden release of the housed at least first agent. Any number of agents, reservoirs, and cap configurations may be possible.