Drug-Eluting Implant Concentration Gradient Trimming
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Solution Overview
Problem
Current drug-eluting medical devices face challenges in achieving a controllable drug release concentration gradient and maintaining the drug payload when trimmed or customized, as the release rate is often dependent on the coating material and trimming can affect the drug distribution.
Innovation Solution
A medical device with a substrate having a central portion and a peripheral portion, featuring a concentration gradient of a bioactive agent that increases from the central to the peripheral portion, allowing for customizable trimming without affecting the total drug payload, with the bioactive agent disposed on the surface or within the substrate, including polymeric capsules for controlled release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a drug-eluting implant is trimmed or cut to customize size, then the device can be adapted to anatomical need, but the drug payload is affected
Solution Approach 1:
The patent applies local quality by creating a non-uniform drug concentration distribution across the implant surface, with higher concentrations at the periphery and lower concentrations toward the center. This spatial variation in drug density ensures that when the implant is trimmed, the remaining peripheral portions retain sufficient drug payload while the central low-drug portions are removed.
2Ease of manufacture
If a uniform drug coating is applied to the implant, then the drug distribution is simple to manufacture, but the release rate cannot be controlled locally
Solution Approach 1:
The patent implements local quality by varying the drug concentration across different regions of the implant surface. The peripheral regions contain higher drug concentrations for sustained release, while central regions have lower concentrations, enabling spatially controlled drug delivery profiles without requiring complex manufacturing processes.
Solution Approach 2:
The patent transitions from a uniform two-dimensional coating to a three-dimensional concentration gradient by varying drug density across the surface area. This dimensional approach to drug distribution enables localized release control while maintaining compatibility with standard coating manufacturing techniques.
3Quantity of substance
If the drug concentration is high throughout the device, then the total drug payload is maximized, but the release rate may be too high in certain areas
Solution Approach 1:
The patent applies local quality by creating a non-uniform drug concentration distribution across the implant surface, with higher concentrations at the periphery and lower concentrations toward the center. This spatial variation in drug density ensures that when the implant is trimmed, the remaining peripheral portions retain sufficient drug payload while the central low-drug portions are removed.
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
Enables tailored localized drug delivery with a controlled release of bioactive agents, maintaining the drug payload during customization and providing therapeutic effectiveness across the device, allowing for precise anatomical adaptation and reduced post-implantation discomfort.
Implementation Method 1
The release of the drug from the coating medium may be dependent upon the nature of the coating material and the drug that is incorporated therein, with drug release occurring by diffusion through the coating material or with degradation of the coating material.
Data Source
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AI summary
A medical device includes a substrate having at least one surface. The surface has a central portion and a peripheral portion. At least one bioactive agent is disposed over at least a portion of the surface. The medical device having a concentration gradient of the at least one bioactive between the central and peripheral portions.