Hydrogel Coating for Medical Devices Resolving Biocompatibility

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Solution Overview

Problem

Medical devices often face issues with biocompatibility due to unsatisfactory surface properties, leading to adverse reactions such as blood clotting, tissue death, and inflammatory responses, particularly with uncoated plastic surfaces like catheters, which stimulate thrombogenic action and inflammatory reactions.

Innovation Solution

A medical device with a hydrogel layer covalently attached to its surface, comprising a biocompatible polymer population including polyethylene glycol (PEG) and polyacrylamide, providing improved resistance to protein interactions and reducing thrombosis, inflammation, and immune system reactions, while maintaining optical clarity and allowing diffusion of biologic molecules.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a medical device surface is made from uncoated plastic materials, then the device can be manufactured easily and is cost-effective, but the surface induces thrombogenic action, blood clotting, and inflammatory reactions

Engineering Contradiction:

Improveease of manufactureVSAvoidthrombogenic action and inflammatory reactions

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

A hydrophilic polymer coating is applied as an intermediary layer between the plastic device surface and the body's blood and tissue. This coating acts as a mediator that prevents direct contact between the plastic surface and biological materials, thereby eliminating thrombogenic action and inflammatory reactions while maintaining the ease of manufacturing the underlying plastic device structure

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The device combines the plastic substrate with a hydrophilic polymer coating to create a composite structure. The plastic provides structural integrity and ease of manufacture, while the hydrophilic polymer layer provides biocompatibility by resisting protein adsorption and preventing thrombus formation, thus resolving the contradiction between manufacturing ease and biological compatibility

Inventive Principle:

Principle #40Composite materials

2Object-affected harmful factors

If a coating is applied to improve biocompatibility, then thrombosis and inflammation are reduced, but the device complexity increases

Engineering Contradiction:

Improvethrombosis and inflammationVSAvoiddevice complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

A thin film hydrophilic polymer coating is applied to the device surface. This thin film approach provides the necessary biocompatibility protection against thrombosis and inflammation without adding significant structural complexity or bulk to the device, maintaining simplicity while achieving the desired biological performance

Inventive Principle:

Principle #30Flexible shells and thin films

3Object-affected harmful factors

If a protein-resistant surface is provided, then undesirable protein adhesion is prevented, but the surface properties must be precisely controlled during fabrication

Engineering Contradiction:

Improveprotein adhesionVSAvoidsurface property control

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The hydrophilic polymer coating is applied with controlled parameters including thickness, composition ratios, and cross-linking density to achieve optimal protein resistance. By carefully controlling these parameters during the coating process, the surface achieves resistance to protein adhesion while maintaining manufacturability through standardized fabrication procedures

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

The hydrogel layer enhances biocompatibility, reduces thrombosis and immune reactions, and improves wettability and lubricity, ensuring the medical device functions without altering the underlying device's functionality, even over long-term implantation.

Implementation Method 1

the hydrogel layer comprises a biocompatible polymer population having a first hydrophilic polymer species including polyethylene glycol (PEG) and a second hydrophilic polymer species including polyacrylamide

Methodology Applied

Scientific EffectProtein resistance:

Implementation Method 2

the first hydrophilic polymer species being at least partially covalently cross-linked to the second hydrophilic polymer species

Methodology Applied

Scientific EffectCovalent cross-linking: Chemical Bonding

Implementation Method 3

allowing diffusion of biologic molecules

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS11260150B2Medical device coating with a biocompatible layer

Publication Date: 2022.03.01 TANGIBLE SCI LLC

AI summary

Medical devices with a hydrogel layer covalently attached to a portion of the outer surface of the medical device are provided along with methods for applying the coating. The hydrogel layer can include a first polymer species comprising polyethylene glycol (PEG) and a second polymer species. Examples of the second polymer species include PEG and polyacrylamide (PAM). The first and second species can be at least partially cross-linked. Methods for forming the hydrogel coatings on the medical devices are provided including nucleophilic conjugate reactions, such as Click reactions.