Microlayer Coextrusion for Sustained Drug Release in Medical Devices
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Solution Overview
Problem
Current medical devices using polymers for drug delivery face challenges in achieving controlled, sustained release of pharmaceutical agents due to limitations in biocompatibility and versatility, particularly in achieving uniform and constant drug release rates.
Innovation Solution
The development of medical devices through microlayer coextrusion, which amplifies laminated flow streams to create thin, nanometer-range geometries with layered biocompatible polymers and drug substances, allowing for controlled time-dependent drug delivery via polymers with tailored diffusivity and biodegradability, enabling uniform and extended release of pharmaceutical agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional polymer materials are used in medical devices, then ease of processing and flexibility are achieved, but controlled and sustained release of pharmaceutical agents is limited
Solution Approach 1:
The patent employs composite materials by combining multiple polymer layers with different properties in a single medical device structure. Each layer can be tailored to provide specific functions - some layers maintain processing ease and flexibility while others provide controlled drug release characteristics, thereby resolving the contradiction between ease of manufacture and reliable controlled release.
Solution Approach 2:
The patent segments the polymer structure into multiple distinct layers, each capable of performing specific functions. This segmentation allows different polymer regions to have different degradation rates, diffusivity characteristics, and mechanical properties, enabling simultaneous achievement of ease of processing in certain layers and controlled drug release in others.
2Duration of action of moving object
If polymer layers are added to control drug release, then sustained release is improved, but device complexity increases
Solution Approach 1:
The patent merges the drug delivery function with the structural polymer matrix by integrating pharmaceutical agents directly into the polymer layers during the extrusion process. This combining approach allows sustained release functionality to be achieved without adding separate, complex delivery mechanisms, thereby extending duration of action while minimizing increases in device complexity.
Solution Approach 2:
The patent utilizes parameter changes in polymer properties such as molecular weight, crystallinity, and composition to control drug release duration. By adjusting these parameters during the extrusion process, the patent achieves sustained release without requiring complex structural modifications or additional components, thus extending duration of action with minimal impact on device complexity.
3Manufacturing precision
If microlayer coextrusion is used to create thin geometries, then delivery precision is improved, but manufacturing complexity increases
Solution Approach 1:
The patent replaces complex mechanical assembly processes with a single extrusion operation that simultaneously creates multiple polymer layers and incorporates drug substances. This substitution of mechanical assembly with a continuous extrusion process achieves high delivery precision through controlled layer thicknesses while minimizing manufacturing complexity by consolidating multiple steps into one operation.
Solution Approach 2:
The patent incorporates drug substances and creates layered structures during the extrusion process itself, rather than assembling components afterward. This preliminary action of incorporating pharmaceutical agents and forming multilayer structures during manufacturing enables precise control over layer thicknesses and drug distribution while avoiding the complexity of subsequent assembly operations.
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 enhances the delivery properties of medical devices by achieving microlayer and polymeric geometries that provide sustained release of drugs, ensuring consistent and prolonged drug release, improving the versatility and effectiveness of medical devices such as catheters, stents, and implants.
Implementation Method 1
In a microlayer extrusion process, each of a laminated flow stream(s) (containing the desired agent(s)) is subject to repeated steps in which the flows are divided and overlapped to amplify the number of laminations
Implementation Method 2
layered with one or more biocompatible materials that control the time release of the delivery of the drug substance
Implementation Method 3
polymers with tailored diffusivity and biodegradability, enabling uniform and extended release of pharmaceutical agents
Data Source
AI summary
The present disclosure relates to medical devices containing time-release drug substance, and more particularly, to medical tubing, catheters, stents, cables (including fiber optic cables), pills, capsules, sheaths, threads, clamps, sutures, and endotracheal devices. The invention also generally relates to a method for extruding multiple laminated flow streams using microlayer coextrusion to create these various time-release drug delivery products.