Solvent-Free Polymer Sections for Biologically Active Agents

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Solution Overview

Problem

Existing medical devices that deliver biologically active agents face challenges with solvent-based coatings, which can damage the device and affect the agent's stability, particularly for protein-based drugs, leading to inconsistent release profiles and performance issues.

Innovation Solution

The development of medical devices comprising multiple polymer sections with biologically active agents incorporated without solvents, where the sections are attached using heat, pressure, or adhesives, allowing for controlled release profiles by managing the exposed surface area and agent concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If solvent-based coatings are used to deliver biologically active agents, then the release profile can be controlled, but the solvent may damage the medical device and affect the stability of the biologically active agent

Engineering Contradiction:

Improvestability of biologically active agentVSAvoiddamage from solvent to device and agent

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the solvent component from the coating system entirely, using only polymer and biologically active agent in a solvent-free formulation. This extraction of the harmful solvent element resolves the contradiction by eliminating the source of damage to both the device and agent while maintaining the coating's drug delivery function.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a composite material system where the polymer and biologically active agent are combined in a solvent-free coating. This composite approach allows the materials to be compatible with each other without requiring a solvent medium, thereby preventing solvent-induced damage while achieving controlled release.

Inventive Principle:

Principle #40Composite materials

2Ease of manufacture

If solvent-based coatings are applied to medical devices, then drug delivery capability is achieved, but the coating process can damage the device structure and affect performance

Engineering Contradiction:

Improvecoating application processVSAvoiddevice integrity and performance

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The harmful solvent is extracted from the coating formulation, leaving only the essential polymer and biologically active agent components. This eliminates the damaging aspect of the coating process while preserving the manufacturing capability of applying a functional coating to the device.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the fundamental parameter of the coating formulation from solvent-based to solvent-free. This parameter change transforms the coating process into one that does not expose the device to harmful solvents, thereby maintaining ease of manufacture while improving device integrity.

Inventive Principle:

Principle #35Parameter changes

3Quantity of substance

If high concentration of biologically active agent is used in coating, then therapeutic effect is enhanced, but release rate becomes unpredictable and may cause adverse effects

Engineering Contradiction:

Improveconcentration of biologically active agentVSAvoidconsistency of release profile

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

The patent uses a composite material system where the polymer and biologically active agent are combined in specific ratios without solvent. This composite structure provides a matrix that controls the release rate, allowing high concentrations of agent to be incorporated while maintaining predictable and consistent release through the polymer matrix.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent changes the formulation parameters by using solvent-free conditions and optimizing the polymer-to-agent ratio. This parameter optimization allows high concentrations of biologically active agent to be incorporated while maintaining controlled and predictable release rates through the polymer matrix structure.

Inventive Principle:

Principle #35Parameter changes

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 enables stable and controlled sustained release of biologically active agents, such as protein-based drugs, with improved stability and uniform dispersion, reducing the risk of high release rates and adverse effects on the device and agent.

Implementation Method 1

capable of delivering drugs to an adjacent tissue

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

sustained release of biologically active agents

Methodology Applied

Scientific EffectPolymer erosion: Decomposition (biological)

Implementation Method 3

The sections can be attached to one another using heat, pressure, or adhesives

Methodology Applied

Scientific EffectHeat: Heating

Implementation Method 4

The sections can be attached to one another using heat, pressure, or adhesives

Methodology Applied

Scientific EffectPressure: Pressure Increase

Data Source

PatentUS9775882B2Medical devices and methods including polymers having biologically active agents therein

Publication Date: 2017.10.03 MEDTRONIC INC

AI summary

Medical devices and methods including polymers having biologically active agents therein are disclosed. The medical devices can be useful as implantable devices such as orthopedic implants.