Drug-Coated Medical Device Layering for Crystalline Stability

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Coating medical devices with multiple drugs in separate layers can affect the properties of the drugs, leading to unintended changes in their release profiles and crystalline structures, making it challenging to maintain the therapeutic effects of each drug.

Innovation Solution

A method for coating medical devices with a first layer comprising a crystalline drug and a second layer comprising a different drug, where the second layer is applied in a solvent that minimizes interaction with the first drug, using a solvent with higher solubility for the second drug to maintain the crystalline form of the first drug, and optimizing process conditions such as spray fineness and temperature to reduce solvent impact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a second layer comprising a second drug is coated on a first layer comprising a first drug, then the device can deliver multiple drugs with different release profiles, but the crystalline structure and release properties of the first drug may be adversely affected

Engineering Contradiction:

Improvemulti-drug delivery capabilityVSAvoidcrystalline structure integrity

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The patent divides the coating into multiple separate layers, with each layer containing a specific drug. The first layer contains the first drug with its desired crystalline structure, and the second layer contains the second drug. This segmentation allows each drug to maintain its independent properties while being delivered from the same device, resolving the contradiction between multi-drug delivery capability and crystalline structure integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent applies different coating compositions to different locations or layers of the device surface. Each layer is formulated with specific properties tailored to its intended drug's release characteristics and stability requirements. This local quality approach ensures that the first drug's crystalline structure is preserved in its layer while the second layer is optimized for the second drug's delivery.

Inventive Principle:

Principle #3Local quality

2Speed

If a polymer-free layer is used to enable rapid drug release, then bioavailability is improved, but the sustained therapeutic effect over weeks or months is reduced

Engineering Contradiction:

Improvedrug release rateVSAvoidsustained therapeutic effect

Core Design Contradiction:

SpeedVSDuration of action of moving object

Solution Approach 1:

The patent segments the drug delivery function into different layers: the first layer uses a polymer-free composition for rapid release and immediate bioavailability, while the second layer uses a polymer-based composition for sustained release over extended periods. This segmentation allows the device to achieve both rapid initial release and long-term sustained effect, resolving the contradiction between release speed and duration of action.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent creates a dynamic release profile where the polymer-free first layer provides an initial burst release for rapid bioavailability, followed by the polymer-based second layer that provides sustained release over weeks or months. The system transitions from rapid release to sustained release over time, adapting to the different phases of therapeutic need.

Inventive Principle:

Principle #15Dynamics

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 allows for the simultaneous coating of multiple drugs on medical devices without substantially affecting the intended properties of the first drug, ensuring sustained release and therapeutic effectiveness of both drugs.

Implementation Method 1

using a solvent with higher solubility for the second drug to maintain the crystalline form of the first drug

Methodology Applied

Scientific EffectSolubility: Solvation

Implementation Method 2

A method for coating medical devices with a first layer comprising a crystalline drug and a second layer comprising a different drug

Methodology Applied

Scientific EffectDeposition: Deposition (physical)

Data Source

PatentUS11951269B2Drug-coated medical devices

Publication Date: 2024.04.09 MEDTRONIC VASCULAR INC

AI summary

A method for coating a medical device includes applying a second layer that includes a second drug on a first layer of on the medical device. The first layer includes a first drug, which may be in crystalline form. By selecting an appropriate solvent use in applying the second layer and appropriate process conditions, the second layer may be applied such that the first drug retains one or more therapeutic properties. For example, the second layer may be applied such that the first drug maintains its crystalline form. The first and second layers may be free of polymer.