Amorphous Bioactive Agent Coating on Hydrophilic Polymer
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Solution Overview
Problem
Current medical devices struggle to effectively deliver bioactive agents from their surface, leading to reduced functional life and potential adverse cellular responses, as existing methods fail to prevent the formation of interpenetrating networks between hydrophilic polymers and bioactive agents, which hampers controlled release and efficacy.
Innovation Solution
A bioactive agent delivery device is developed with a hydrophilic polymer coating on a substrate, where a substantially amorphous bioactive agent is deposited using a solvent that does not solvate the polymer, preventing network formation and enhancing release by using photo-polymers with latent photoreactive groups to form a secure coating, and applying actinic radiation for cross-linking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hydrophilic polymer coating is applied to the substrate to deliver bioactive agents, then the device can release bioactive agents to prevent cellular responses and treat medical conditions, but an interpenetrating network forms between the polymer and bioactive agent which hampers controlled release and reduces efficacy
Solution Approach 1:
The device structure is segmented into distinct layers: a substrate, a hydrophilic polymer coating layer, and a bioactive agent layer. This segmentation prevents interpenetration by maintaining physical separation between the polymer and bioactive agent, allowing controlled release without network formation that would hamper efficacy.
Solution Approach 2:
The hydrophilic polymer coating acts as an intermediary layer between the substrate and the bioactive agent. This intermediate layer controls the release of the bioactive agent while preventing direct interaction and interpenetration with the substrate, thereby maintaining composition stability and delivery efficacy.
2Productivity
If conventional deposition methods are used to apply bioactive agents on the polymer surface, then the manufacturing process is simple, but the amount of bioactive agent released is insufficient, reducing device effectiveness
Solution Approach 1:
The deposition process parameters are optimized to enhance bioactive agent loading and release. By controlling parameters such as deposition conditions, polymer composition, and layer thickness, the system achieves up to 150% increased bioactive agent release while maintaining a relatively simple manufacturing process.
3Duration of action of stationary object
If the hydrophilic polymer and bioactive agent are allowed to interact freely, then the coating process is straightforward, but an interpenetrating network forms that reduces controlled release capability and device longevity
Solution Approach 1:
The coating structure is segmented into distinct functional layers that prevent unwanted interaction between the hydrophilic polymer and bioactive agent. This layered segmentation maintains device longevity by preventing network formation while preserving a relatively simple overall device structure.
Solution Approach 2:
A thin film of hydrophilic polymer is applied as a coating on the substrate, creating a flexible barrier that controls bioactive agent release. This thin film approach extends device functional life by preventing direct contact between the bioactive agent and substrate, avoiding interpenetration and network formation.
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
This approach significantly enhances the delivery and transfer of bioactive agents, as shown in examples with paclitaxel, increasing the amount of bioactive agent released by up to 150% compared to control devices, thereby improving the longevity and effectiveness of medical devices like balloon catheters.
Implementation Method 1
depositing a photo-polymer on the substrate, the photo-polymer comprising latent photoreactive groups and a hydrophilic backbone; and applying actinic radiation to the photo-polymer. The use of a photo-polymer can result in formation of covalent bonds between the hydrophilic polymer and substrate leading to a structurally secure coating.
Implementation Method 2
The use of a solvent when depositing the bioactive agent that does not solvate the hydrophilic polymer can prevent the formation of an interpenetrating network between the hydrophilic polymer and the bioactive agent.
Data Source
AI summary
Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.