Alginate-Pectin Coated Bone Substitute for Sustained Antibiotic Release

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Solution Overview

Problem

Current bone substitutes and antibiotic formulations for orthopedic implantations face challenges in effectively preventing and treating infections due to limited release kinetics and variable antibiotic distribution, particularly in septic revisions where high infection probabilities exist.

Innovation Solution

A tissue substitute material with a controlled release coating made from a biocompatible polymer combination of alginic acid and pectin, where sodium alginate is converted into calcium alginate, allowing for extended release of antibiotics like gentamicin, ciprofloxacin, and vancomycin, enhancing bacterial growth inhibition and tissue integration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If antibiotics are applied systemically or on the spot during surgery, then bacterial infection can be addressed, but the required local concentration of antibiotics cannot be reached due to low metabolic rate of bone tissue and formation of bacterial biofilm

Engineering Contradiction:
Improvelocal antibiotic concentrationVSAvoidinfection prevention effectiveness
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent applies preliminary action by pre-coating the bone substitute material with antibiotics before implantation. This ensures that the antibiotic is already positioned at the implant site with proper concentration, eliminating the need for systemic administration and ensuring immediate local effect upon implantation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses an intermediary carrier system where antibiotics are bound to bone substitute material through specific coating techniques. This intermediary approach allows controlled local delivery of antibiotics directly at the infection site, overcoming the limitations of systemic administration and biofilm formation barriers.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If local antibiotic treatment is applied to support systemic antibiotics, then infection treatment is enhanced, but the release kinetics and dosing optimization remain unknown

Engineering Contradiction:
Improveinfection treatment effectivenessVSAvoiddosing optimization complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by systematically varying antibiotic concentration, coating thickness, and release kinetics parameters during development. This allows optimization of the local antibiotic formulation to achieve desired release profiles and dosing effectiveness without requiring complex post-implantation adjustments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements self-service through self-regulating release mechanisms where the coating system automatically controls antibiotic release based on local conditions. The formulation is designed to provide sustained release without requiring external control or complex dosing schedules, simplifying the treatment protocol.

Inventive Principle:
Principle #25Self-service

3Adaptability or versatility

If different antibiotic formulations are available for different surgical cases, then specific infection scenarios can be addressed, but the complexity of selecting and managing multiple formulations increases

Engineering Contradiction:
Improveformulation specificity for different casesVSAvoidformulation selection and management
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent applies universality by developing a platform technology with a core coating system that can accommodate multiple antibiotic agents and formulation variations. This multi-functional approach allows a single base product to be adapted for different surgical scenarios (primary implantation, aseptic revision, septic revision) by changing the antibiotic component rather than requiring entirely separate formulations.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 material achieves sustained antibiotic release for up to 50 days, effectively preventing and treating infections by maintaining therapeutic antibiotic levels, reducing the risk of overdosing, and promoting tissue integration.

Implementation Method 1

a controlled release coating containing at least one biologically active substance that decreases bacterial growth

Methodology Applied
Scientific EffectControlled release: Diffusion

Implementation Method 2

the (b) controlled release coating is a bioavailable, biocompatible polymer material

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP2953657B1Tissue substitute material with biologically active coating
Publication Date: 2019.06.05 LACERTA TECHNOLOGY LTD
  • EP2953657B1 patent drawingFigure 1~2B
  • EP2953657B1 patent drawingFigure 3~4

AI summary

The present invention relates to a tissue substitute material for implantation, comprising (a) a substrate to be implanted covered with (b) a controlled release coating containing (c) at least one biologically substance that decreases bacterial growth, wherein the (b) controlled release coating is a bioavailable, biocompatible polymer material and wherein the (c) at least one biologically active substance that decreases bacterial growth. The present invention also relates to a method to prepare the tissue substitute material, as wells the uses thereof.