Cross-linked Gel Barrier Layer for Adhesion Prevention

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Solution Overview

Problem

Existing biocompatible medical films and meshes for adhesion prevention in surgical settings are difficult to handle due to their chemical makeup and bio-dissolvable properties, leading to structural weaknesses such as tearing and folding, and often cause chronic inflammation.

Innovation Solution

A non-polymeric cross-linked gel barrier layer derived from fatty acid compounds, including omega-3 fatty acids, is applied to medical devices like meshes, providing a biological and physical anti-adhesion barrier that is bio-absorbable and non-inflammatory, allowing for controlled release of therapeutic agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If bio-dissolvable films are made thin to minimize tissue disruption, then tissue damage is reduced, but structural strength deteriorates making them easily torn or folded during handling

Engineering Contradiction:
Improvetissue disruptionVSAvoidstructural strength
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent combines a bio-dissolvable polymer matrix with natural oil components (fatty acids, triglycerides, cholesterol esters) to create a composite barrier layer. This composite structure provides both the thin-film benefits for tissue protection and the enhanced structural integrity from the cross-linked oil network, preventing tearing and folding during surgical handling.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of the barrier layer by incorporating cross-linking agents and specific oil compositions. These parameter changes increase the mechanical strength and handleability of the thin film while maintaining its bio-dissolvable properties and thin-profile advantage for minimizing tissue disruption.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If traditional polymer-based anti-adhesion films are used, then adhesion prevention is achieved, but chronic inflammation is caused at the local tissue level

Engineering Contradiction:
Improveadhesion preventionVSAvoidchronic inflammation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent employs a bio-dissolvable barrier layer composed of natural oil components that are temporarily present during the critical adhesion prevention period and then naturally absorbed and metabolized by the body. This short-lived, biocompatible material provides reliable adhesion prevention without the chronic inflammation associated with persistent synthetic polymers, as the material is completely absorbed without foreign body reaction.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the chemical composition parameters from synthetic polymers to natural oil-based compounds (fatty acids, triglycerides, cholesterol esters). This compositional parameter change maintains the anti-adhesion functionality while eliminating the chronic inflammatory response, as these natural components are biocompatible and metabolizable by human tissue.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If conventional bio-dissolvable films are handled with dry hands or instruments, then adhesion prevention properties are maintained, but ease of operation deteriorates during surgical intervention

Engineering Contradiction:
Improveadhesion prevention propertiesVSAvoidease of handling
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent modifies the surface properties and handling characteristics of the barrier layer by incorporating specific oil components and cross-linking agents. These parameter changes improve the mechanical handleability and reduce tearing/folding during surgical manipulation while maintaining the integrity of the adhesion prevention properties through proper formulation and application techniques.

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 barrier layer effectively reduces postoperative adhesions, minimizes tissue injury and inflammation, and enables targeted delivery of therapeutic agents without causing inflammatory responses, improving handling and efficacy compared to traditional polymer-based solutions.

Implementation Method 1

a non-polymeric cross-linked gel barrier layer which is bio-absorbable and non-inflammatory, allowing for controlled release of therapeutic agents

Methodology Applied
Scientific EffectBio-absorption: Absorption (physical)

Implementation Method 2

providing a biological and physical anti-adhesion barrier

Methodology Applied
Scientific EffectPhysical barrier: Physical Containment

Implementation Method 3

molecules covalently cross-linked into a three-dimensional network by one or more of ester, ether, peroxide, and carbon-carbon bonds

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentUS9801913B2Barrier layer
Publication Date: 2017.10.31 ATRIUM MEDICAL CORP
  • US9801913B2 patent drawing
  • US9801913B2 patent drawing
  • US9801913B2 patent drawing

AI summary

A barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.