Bioabsorbable Coated Stent with Crystalline Drug Layers
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Solution Overview
Problem
Current drug-eluting stents face challenges in minimizing physical, chemical, and therapeutic legacy in vessels after a certain period, and they often have thick cross-sectional profiles that limit flexibility and access to small and large vessels.
Innovation Solution
A coated stent with a bioabsorbable polymer and pharmaceutical or biological agents is developed, featuring a conformal coating that adheres to and contacts a significant portion of the stent's surfaces, using a method that includes depositing layers with a ratio of abluminal to luminal coating thickness optimized for minimal intrusion and controlled drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a drug-eluting stent is designed with a thick cross-sectional profile to ensure adequate drug loading and structural support, then the drug delivery capability and structural strength are improved, but the flexibility of deployment and access to small vessels deteriorates
Solution Approach 1:
The stent employs a thin-film coating approach where the drug-eluting coating is applied as a conformal layer on the stent struts. This thin-film structure provides adequate drug loading capacity while maintaining the flexibility and low profile needed for deployment in small vessels, resolving the contradiction between structural strength and adaptability.
Solution Approach 2:
The stent utilizes composite material construction combining the metallic stent framework with a polymer drug-eluting coating layer. This composite structure allows the thin metallic struts to provide structural support while the coating layer provides drug delivery functionality, achieving both strength and flexibility requirements simultaneously.
2Quantity of substance
If the stent coating thickness is increased to improve drug loading capacity, then the therapeutic efficacy is improved, but the cross-sectional thickness and intrusion into the vessel wall increase
Solution Approach 1:
The patent applies thin-film coating technology to deliver adequate drug quantities in a minimized thickness. The conformal coating process ensures uniform drug distribution across the stent surface, achieving high drug loading capacity without increasing the cross-sectional thickness that would cause vessel wall intrusion.
Solution Approach 2:
The patent optimizes the coating thickness parameter to achieve the desired drug loading capacity while maintaining minimal intrusion. By carefully controlling and optimizing the coating thickness parameter, the stent achieves sufficient therapeutic drug load without excessive cross-sectional dimensions that would limit vessel access.
3Stability of the object's composition
If a conformal coating is applied to all surfaces of the stent struts, then the drug delivery uniformity is improved, but the manufacturing complexity increases
Solution Approach 1:
The coating process is designed to simultaneously coat all surfaces of the stent struts (luminal, abluminal, and sidewall surfaces) in a single operation. This universal coating approach achieves uniform drug delivery across all surfaces without requiring multiple separate coating steps, thereby maintaining manufacturing simplicity while ensuring composition stability.
Data Source
AI summary
Provided herein is a coated coronary stent, comprising: a. stent; b. a plurality of layers deposited on said stent to form said coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.