Biodegradable Elastomer Coating for Controlled Taxane Release
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
There is a need for an implantable medical device capable of releasing a therapeutic agent, such as a taxane agent, at a controlled rate and duration to prevent restenosis without premature release during transportation and implantation, while ensuring durability and effective delivery to the target site within a body vessel.
Innovation Solution
A multi-layer coating system for implantable medical devices, comprising a first layer of taxane agent, specifically paclitaxel in amorphous, anhydrous, or dihydrate forms, and a second layer of biodegradable elastomer, applied using specific solvents and methods to ensure controlled release and durability, with the biodegradable elastomer having a molecular weight of 75,000 - 240,000 Da and a weight ratio between 1:1 to 1:20 compared to the taxane agent.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a therapeutic agent is coated on the medical device, then therapeutic efficacy is improved, but premature release during transportation and implantation occurs
Solution Approach 1:
The coating is divided into multiple functional layers: a first layer containing the therapeutic agent and a second layer containing the biodegradable elastomer. This segmentation allows the therapeutic agent to be protected within the layered structure, preventing premature release during transportation and implantation, while enabling controlled release at the target site.
Solution Approach 2:
The biodegradable elastomer acts as an intermediary material between the therapeutic agent and the external environment. It controls the release rate of the therapeutic agent, preventing premature release while ensuring therapeutic efficacy is achieved at the target site over time.
2Strength
If the coating is made more durable to withstand physical forces, then durability is improved, but controlled release of therapeutic agent may be affected
Solution Approach 1:
The coating uses composite materials consisting of a biodegradable elastomer combined with the therapeutic agent in a matrix. This composite structure provides the necessary durability to withstand physical forces during implantation while maintaining the ability to release the therapeutic agent in a controlled manner over the desired time period.
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 coating system effectively delivers the taxane agent over a desired period, maintaining durability and preventing premature release, ensuring therapeutic efficacy while withstanding physical forces during deployment and expansion within the body vessel.
Implementation Method 1
comprising a biodegradable elastomer and a taxane agent
Implementation Method 2
wherein the taxane agent is paclitaxel comprising one of amorphous paclitaxel and anhydrous paclitaxel and at least 20% of dihydrate solid form of paclitaxel
Data Source
Figure 1A~1C
Figure 2A~2B
Figure 3A
AI summary
A coated medical device, such as a stent, that elutes a taxane agent in a controlled manner is provided. In one embodiment, the taxane agent is paclitaxel and at least a portion of the paclitaxel is present in a dihydrate solid form. The medical device may be coated with a layer including a taxane agent and a layer of bioabsorbable elastomer over the layer including the taxane agent. Methods of manufacturing and using the coated medical device are also provided.