Taxane Coating Solid Form Control for Implantable Devices
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Solution Overview
Problem
There is a need for medical device coatings with taxane therapeutic agents that can control the release rate of paclitaxel without compromising durability, as existing coatings either release the agent too quickly or are not durable enough, and current packaging systems do not adequately protect these coatings from environmental factors.
Innovation Solution
A method of conditioning medical device coatings to alter the solid form of taxane therapeutic agents, such as converting amorphous paclitaxel to dihydrate paclitaxel, to slow the release rate while maintaining durability, without using polymers, and using specialized packaging to regulate ambient conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a taxane therapeutic agent coating is applied to an implantable medical device, then the therapeutic effect is improved, but the coating durability deteriorates
Solution Approach 1:
The patent applies parameter changes by controlling the solid form composition of taxane (amorphous vs. crystalline) and using conditioning treatments (humidity, temperature, time) to modify the coating properties. This resolves the contradiction by finding optimal parameter combinations that provide both therapeutic efficacy and coating durability without requiring polymer additives.
2Reliability
If the release rate of paclitaxel is increased, then the therapeutic effect is improved, but the elution period is shortened
Solution Approach 1:
The patent uses parameter changes in the solid form composition (amorphous/crystalline ratio) of taxane to control the release kinetics. By adjusting these parameters, the coating can be tuned to provide both high release rate and extended elution period, resolving the contradiction between therapeutic effect and duration of action.
3Duration of action of moving object
If polymer materials are used to control release rate, then the elution period is extended, but the coating complexity increases
Solution Approach 1:
The patent extracts the polymer component from the coating system and replaces it with carefully controlled solid forms of taxane itself (amorphous and crystalline phases). This eliminates the need for additional polymer materials while maintaining control over release kinetics, thus extending elution period without increasing coating complexity.
Solution Approach 2:
The patent uses amorphous and crystalline solid forms of taxane as intermediary phases that mediate the release kinetics. These solid forms act as natural rate-controlling mechanisms, replacing the need for polymer mediators and simplifying the overall coating system while extending the elution 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 method effectively slows the release rate of paclitaxel from medical device coatings, ensuring a longer elution period within the body while maintaining the coating's durability and stability during transport and implantation.
Implementation Method 1
converting amorphous paclitaxel to dihydrate paclitaxel
Data Source
AI summary
This disclosure relates to endolumenal medical devices coated with a taxane therapeutic agent in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous paclitaxel, dihydrate paclitaxel, or combinations thereof that provide durable coatings that release paclitaxel over a desired period of time, which can be on the order of hours, days or weeks. Preferred embodiments relate to medical device coatings of paclitaxel, or paclitaxel analogs or derivatives, having one or more polymorph solid forms that provide a prolonged release of paclitaxel within a body vessel without requiring a polymer carrier or barrier layer to achieve the desired rate of paclitaxel elution.